Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
DiaDent Group International
REGULAR KIT
In Commercial Distribution

  • 08806383568760 ()
4008-1001

  • Dental/surgical polymerization lamp
D-Lux is a dental curing light which is used for polymerization resinous dental materials
DiaDent Group International
D-Lux LIGHT GUIDE (WHITE)
In Commercial Distribution

  • 08806383552868 ()
4004-1131

  • Dental/surgical polymerization lamp
D-Lux is a dental curing light which is used for polymerization resinous dental materials
DiaDent Group International
D-Lux BATTERY PACK
In Commercial Distribution

  • 08806383540933 ()
4004-1150

  • Dental/surgical polymerization lamp
D-Lux is a dental curing light which is used for polymerization resinous dental materials
DiaDent Group International
D-Lux LIGHT GUIDE (BLACK)
In Commercial Distribution

  • 08806383540926 ()
4004-1130

  • Dental/surgical polymerization lamp
D-Lux is a dental curing light which is used for polymerization resinous dental materials
DiaDent Group International
D-Lux CHARGER
In Commercial Distribution

  • 08806383540919 ()
4004-1120

  • Dental/surgical polymerization lamp
D-Lux is a dental curing light which is used for polymerization resinous dental materials
DiaDent Group International
D-Lux HANDPIECE
In Commercial Distribution

  • 08806383540902 ()
4004-1110

  • Dental/surgical polymerization lamp
D-Lux is a dental curing light which is used for polymerization resinous dental materials
DiaDent Group International
Regular Kit
In Commercial Distribution

  • 08806383540896 ()
4004-1001

  • Dental/surgical polymerization lamp
The bolt is used to secure the construct and is manufactured from stainless steel.
Ascension Orthopedics, Inc.
12224251
In Commercial Distribution

  • 10381780125242 ()

  • 10 mm hex x 14 mm L
12224251

  • External orthopaedic fixation system, reusable
This lid is used with the implant tray insert which product number is 339911ND.
NEWDEAL
339912ND
Not in Commercial Distribution

  • M248339912ND1 ()
  • 10381780042716 ()


  • Device sterilization/disinfection container, reusable
The bolt is used to secure the construct and is manufactured from stainless steel.
Ascension Orthopedics, Inc.
12224252
In Commercial Distribution

  • 10381780125259 ()

  • 10 mm hex x 18 mm L
12224252

  • External orthopaedic fixation system, reusable
The bolt is used to secure the construct and is manufactured from stainless steel.
Ascension Orthopedics, Inc.
12224250
In Commercial Distribution

  • 10381780125235 ()

  • 10mm hex x 10 mm L
12224250

  • External orthopaedic fixation system, reusable
The device is a stretcher in carbon fiber and it is raised via an hydraulic piston mechanism which is controlled by a foot-pedal.
GENERAL MEDICAL MERATE SPA
STRETCHER
In Commercial Distribution

  • 08054890480031 ()

  • Width: 65 Centimeter
  • Length: 210 Centimeter


  • Radiographic stretcher
The washer is used in conjunction with the Integra External Fixation System. It is made from stainless steel and is rectangular in shape.
Ascension Orthopedics, Inc.
12224201
In Commercial Distribution

  • 10381780125082 ()

  • 2mm H
12224201

  • External orthopaedic fixation system, reusable
The reamers tray is part of the container which product number is 519900ND and that is used for transport and sterilization of instruments.
NEWDEAL
519911ND
Not in Commercial Distribution

  • M248519911ND1 ()
  • 10381780042754 ()


  • Device sterilization/disinfection container, reusable
The washer is used in conjunction with the Integra External Fixation System. It is made from stainless steel and is rectangular in shape.
Ascension Orthopedics, Inc.
12224202
In Commercial Distribution

  • 10381780125099 ()

  • 4 mm H
12224202

  • External orthopaedic fixation system, reusable
Black Nitrile Exam Gloves, Powder Free, Size Double Extra Large (XXL)
Strong Medical Partners LLC
1406
In Commercial Distribution

  • 10850005354823 ()
  • 00850005354826 ()

  • Double Extra Large (XXL)
  • Glove thickness is 0.12 mm or 5.0 Mils
1406

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Nitrile Pro Exam Gloves, Blue, Powder Free, Size Double Extra Large (XXL), Non-Sterile, 900 ea per case
Strong Medical Partners LLC
71046
In Commercial Distribution

  • 10850005354267 ()
  • 00850005354260 ()

  • Double Extra Large (XXL)
  • Glove thickness is 0.10 mm or 4.0 Mils
71046

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
N/A
Conformis, Inc.
RPS010200001
In Commercial Distribution

  • M572RPS0102000011 ()

  • 20 mm thick on the medial side, lateral side is patient specific
RPS0102000

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
N/A
Conformis, Inc.
RPS010150001
In Commercial Distribution

  • M572RPS0101500011 ()

  • 15 MM THICK ON THE MEDIAL SIDE,LATERAL SIDE IS PATIENT SPECIFIC
RPS0101500

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
N/A
Conformis, Inc.
RPS010060001
In Commercial Distribution

  • M572RPS0100600011 ()

  • 6 mm thick on the medial side, lateral side is patient specific
RPS0100600

  • Total knee prosthesis implantation guide-instrument kit
  • Tibial insert
Scale, Stand-on, patient. A stand-on patient scale is a device that is intended for medical purposes that is used to weigh a patient who is able to stand on the scale platform.
Lark Technologies, Inc.
LK-GBS-2104-G
In Commercial Distribution

  • 00860008199140 ()


  • Stand-on floor scale, electronic
Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildups. This product is Blue shade. This product is Non-Fluoride. This product is a Luer Lok Syringe
RELIANCE ORTHODONTIC PRODUCTS INC
1NFLLUBLBPP
In Commercial Distribution

  • D7981NFLLUBLBPP0 ()
1NFLLUBLBPP

  • Dental composite resin
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6555LT
Not in Commercial Distribution

  • M269PSS6555LT1 ()
  • 10381780118183 ()

  • 2.325 in L x .256 in dia
PSS6555LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6545LT
Not in Commercial Distribution

  • M269PSS6545LT1 ()
  • 10381780118145 ()

  • 1.932 in L x .256 in dia
PSS6545LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6520LT
Not in Commercial Distribution

  • M269PSS6520LT1 ()
  • 10381780117964 ()

  • .947 in L x .256 in dia
PSS6520LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4580CT
Not in Commercial Distribution

  • M269PSS4580CT1 ()
  • 10381780117940 ()

  • 3.291 in L x .177 in dia
PSS4580CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4575LT
Not in Commercial Distribution

  • M269PSS4575LT1 ()
  • 10381780117933 ()

  • 3.093 in L x .177 in dia
PSS4575LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4570LT
Not in Commercial Distribution

  • M269PSS4570LT1 ()
  • 10381780117919 ()

  • 2.896 in L x .177 in dia
PSS4570LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4565CT
Not in Commercial Distribution

  • M269PSS4565CT1 ()
  • 10381780117889 ()

  • 2.700 in L x .177 in dia
PSS4565CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4560CT
Not in Commercial Distribution

  • M269PSS4560CT1 ()
  • 10381780117865 ()

  • 2.503 in L x .177 in dia
PSS4560CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4550LT
Not in Commercial Distribution

  • M269PSS4550LT1 ()
  • 10381780117834 ()

  • 2.109 in L x .177 in dia
PSS4550LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4545LT
Not in Commercial Distribution

  • M269PSS4545LT1 ()
  • 10381780117810 ()

  • 1.912 in L x .177 in dia
PSS4545LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4545CT
Not in Commercial Distribution

  • M269PSS4545CT1 ()
  • 10381780117803 ()

  • 1.913 in L x .177 in dia
PSS4545CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS4540LT
Not in Commercial Distribution

  • M269PSS4540LT1 ()
  • 10381780117797 ()

  • 1.715 in L x .177 in dia
PSS4540LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6580LT
Not in Commercial Distribution

  • M269PSS6580LT1 ()
  • 10381780118282 ()

  • 3.310 in L x .256 in dia
PSS6580LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6580CT
Not in Commercial Distribution

  • M269PSS6580CT1 ()
  • 10381780118275 ()

  • 3.291 in L x .256 in dia
PSS6580CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6575LT
Not in Commercial Distribution

  • M269PSS6575LT1 ()
  • 10381780118268 ()

  • 3.113 in L x .256 in dia
PSS6575LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6575CT
Not in Commercial Distribution

  • M269PSS6575CT1 ()
  • 10381780118251 ()

  • 3.094 in L x .256 in dia
PSS6575CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6570LT
Not in Commercial Distribution

  • M269PSS6570LT1 ()
  • 10381780118244 ()

  • 2.916 in L x .256 in dia
PSS6570LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6570CT
Not in Commercial Distribution

  • M269PSS6570CT1 ()
  • 10381780118237 ()

  • 2.897 in L x .256 in dia
PSS6570CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6565LT
Not in Commercial Distribution

  • M269PSS6565LT1 ()
  • 10381780118220 ()

  • 2.719 in L x .256 in dia
PSS6565LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6565CT
Not in Commercial Distribution

  • M269PSS6565CT1 ()
  • 10381780118213 ()

  • 2.700 in L x .256 in dia
PSS6565CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6560LT
Not in Commercial Distribution

  • M269PSS6560LT1 ()
  • 10381780118206 ()

  • 2.522 in L x .256 in dia
PSS6560LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6560CT
Not in Commercial Distribution

  • M269PSS6560CT1 ()
  • 10381780118190 ()

  • 2.503 in L x .256 in dia
PSS6560CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6555CT
Not in Commercial Distribution

  • M269PSS6555CT1 ()
  • 10381780118176 ()

  • 2.306 in L x .256 in dia
PSS6555CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6550LT
Not in Commercial Distribution

  • M269PSS6550LT1 ()
  • 10381780118169 ()

  • 2.129 in L x .256 in dia
PSS6550LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6550CT
Not in Commercial Distribution

  • M269PSS6550CT1 ()
  • 10381780118152 ()

  • 2.110 in L x .256 in dia
PSS6550CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6545CT
Not in Commercial Distribution

  • M269PSS6545CT1 ()
  • 10381780118138 ()

  • 1.913 in L x .256 in dia
PSS6545CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Locking Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6540LT
Not in Commercial Distribution

  • M269PSS6540LT1 ()
  • 10381780118121 ()

  • 1.735 in L x .256 in dia
PSS6540LT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
Compression Screw is used with the Construct® Ankle Fusion Plate System . The screw is manufactured from titanium and is a machined, metallic screws with a cannulation that is self-drilling and self-tapping.
Ascension Orthopedics, Inc.
PSS6540CT
Not in Commercial Distribution

  • M269PSS6540CT1 ()
  • 10381780118114 ()

  • 1.716 in L x .256 in dia
PSS6540CT

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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