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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+ - 08806383568814

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

  • 08806383568814 ()
4008-1150

  • Dental/surgical polymerization lamp

D-LUX+ - 08806383568807

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

  • 08806383568807 ()
4008-1140

  • Dental/surgical polymerization lamp

D-LUX+ - 08806383568791

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

  • 08806383568791 ()
4008-1130

  • Dental/surgical polymerization lamp

D-LUX+ - 08806383568784

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

  • 08806383568784 ()
4008-1120

  • Dental/surgical polymerization lamp

D-LUX+ - 08806383568777

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

  • 08806383568777 ()
4008-1110

  • Dental/surgical polymerization lamp

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+ - 08806383580939

D-Lux+ is a dental curing light which is used for polymerization resinous dental materials.
DiaDent Group International
Light Probe Silicone Ring
In Commercial Distribution

  • 08806383580939 ()
4008-1180

  • Dental/surgical polymerization lamp

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 - 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

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

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

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

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

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

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 - 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

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

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 - 10381780118282

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

Construct® Ankle Fusion Plate System - 10381780118275

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

Construct® Ankle Fusion Plate System - 10381780118268

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

Construct® Ankle Fusion Plate System - 10381780118251

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

Construct® Ankle Fusion Plate System - 10381780118244

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

Construct® Ankle Fusion Plate System - 10381780118237

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

Construct® Ankle Fusion Plate System - 10381780118220

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

Construct® Ankle Fusion Plate System - 10381780118213

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

Construct® Ankle Fusion Plate System - 10381780118206

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

Construct® Ankle Fusion Plate System - 10381780118190

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

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 - 10381780118176

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

Construct® Ankle Fusion Plate System - 10381780118169

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

Construct® Ankle Fusion Plate System - 10381780118152

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

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 - 10381780118138

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

Construct® Ankle Fusion Plate System - 10381780118121

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

Construct® Ankle Fusion Plate System - 10381780118114

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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