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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+ - 08806383568760

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 - 08806383552868

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 - 08806383540933

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 - 08806383540926

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 - 08806383540919

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 - 08806383540902

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 - 08806383540896

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

Integra® External Fixation System - 10381780125242

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

UNI-CP™ - 10381780042716

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

Integra® External Fixation System - 10381780125259

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

Integra® External Fixation System - 10381780125235

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

OPERA SWING - 08054890480031

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

Integra® External Fixation System - 10381780125082

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

PANTA® - 10381780042754

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

Integra® External Fixation System - 10381780125099

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

Strong Manufacturers - 00850005354826

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

Strong Manufacturers - 00850005354260

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

iTotal® PS iPoly® Insert Kit - M572RPS0102000011

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

iTotal® PS iPoly® Insert Kit - M572RPS0101500011

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

iTotal® PS iPoly™ Insert Kit - M572RPS0100600011

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

Lark Technologies, Inc - 00860008199140

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 - D7981NFLLUBLBPP0

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

Construct® Ankle Fusion Plate System - 10381780118183

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

Construct® Ankle Fusion Plate System - 10381780118145

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

Construct® Ankle Fusion Plate System - 10381780117964

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

Construct® Ankle Fusion Plate System - 10381780117940

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

Construct® Ankle Fusion Plate System - 10381780117933

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

Construct® Ankle Fusion Plate System - 10381780117919

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

Construct® Ankle Fusion Plate System - 10381780117889

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

Construct® Ankle Fusion Plate System - 10381780117865

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
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