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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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Thiol Broth 4 mL Solution in 12x80 NEW Tube
COPAN ITALIA SPA
4U002N
In Commercial Distribution

  • 28053326000328 ()
  • 18053326000321 ()
  • 08053326000324 ()
4U002N

  • General specimen container IVD, additive/medium
Personal Use Kit OC-Auto, for Trinity Health New England
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-THNE
In Commercial Distribution

  • 00816917027128 ()


  • Faecal occult blood IVD, reagent
Personal Use Kit OC-Auto, for Yale New Haven Medical
POLYMEDCO CANCER DIAGNOSTIC PRODUCTS LLC
OCPU-YNHM
In Commercial Distribution

  • 00816917024547 ()


  • Faecal occult blood IVD, reagent
2 x 50 ml EasySoft Liner cartridges
Karlin Dental Distributors Inc
0517
In Commercial Distribution

  • 00627843583790 ()

  • Total Volume: 50 Milliliter


  • Denture reliner, soft, professional
No Description
Karlin Dental Distributors Inc
0503
In Commercial Distribution

  • 00627843583783 ()


  • Denture reliner, soft, professional
4 x 50 ml EasySoft liner 2 x 10 ml EasySoft liner adhesive (28 mixing tips that are only used outside of the mouth and are not medical devices)
Karlin Dental Distributors Inc
0502
In Commercial Distribution

  • 00627843583776 ()

  • Total Volume: 50 Milliliter
  • Total Volume: 10 Milliliter


  • Denture reliner, soft, professional
2 x 50 ml EasySoft Liner 1 x 50 ml EasySoft Liner Sealant 1 x 10 ml EasySoft Liner Adhesive (mixing tips, brushes, polishing discs and mandrel are all used outside of mouth and are not medical devices)
Karlin Dental Distributors Inc
0501
In Commercial Distribution

  • 00627843583769 ()

  • Total Volume: 10 Milliliter
  • Total Volume: 50 Milliliter


  • Denture reliner, soft, professional
No Description
Karlin Dental Distributors Inc
0504
In Commercial Distribution

  • 00627843583752 ()

  • Total Volume: 10 Milliliter


  • Denture reliner, soft, professional
GC RELINE™ II Disposable Brush (6)
Gc America Inc.
010282
In Commercial Distribution

  • 14548161321457 ()
010282

  • Denture reliner, soft, professional
GC RELINE™ II Wheel for Finishing (12)
Gc America Inc.
010279
In Commercial Distribution

  • 14548161321440 ()
010279

  • Denture reliner, soft, professional
GC RELINE ™ II Point for Trimming (3)
Gc America Inc.
010276
In Commercial Distribution

  • 14548161321433 ()
010276

  • Denture reliner, soft, professional
GC RELINE™ II Remover (for Resin): 1 x 5g (5.5mL)
Gc America Inc.
010274
In Commercial Distribution

  • 14548161321426 ()
010274

  • Denture reliner, soft, professional
GC RELINE™ II Primer for Resin: 1 x 8g (10mL)
Gc America Inc.
010272
In Commercial Distribution

  • 14548161321419 ()
010272

  • Denture reliner, soft, professional
GC RELINE™ II Finishing Material: 1 each A & B 10g(9mL)
Gc America Inc.
010270
In Commercial Distribution

  • 14548161321402 ()
010270

  • Denture reliner, soft, professional
GC RELINE™ II Cartridge ExtraSoft: 1 x57g (48mL)
Gc America Inc.
010267
In Commercial Distribution

  • 14548161321396 ()
010267

  • Denture reliner, soft, professional
GC RELINE™ II Cartridge Soft: 1 x 61g (48mL)
Gc America Inc.
010264
In Commercial Distribution

  • 14548161321389 ()
010264

  • Denture reliner, soft, professional
GC RELINE™ II Intro Kit ExtraSoft contains: 1 GC RELINE II Cartridge ExtraSoft 57g (48mL), 1 GC RELINE II Primer for Resin 8g (10mL), 1 GC RELINE II Point for Trimming, 1 GC RELINE II Wheel for Finishing, 1 GC RELINE II Remover for Resin 5g(5.5mL), 6 pieces Mixing Tip II L, 3 disposable brushes, 1 plastic spatula
Gc America Inc.
010261
In Commercial Distribution

  • 14548161321372 ()
010261

  • Denture reliner, soft, professional
GC RELINE™ II Intro Kit Soft contains: 1 GC RELINE II Cartridge Soft 61g(48mL), 1 GC RELINE II Primer for Resin 8g(10mL), 1 GC RELINE II Point for Trimming, 1 GC RELINE II Wheel for Finishing, 1 GC RELINE II Remover for Resin 5g(5.5mL), 6 pieces Mixing Tip II L, 3 Disposable brushes, 1 plastic spatula
Gc America Inc.
010258
In Commercial Distribution

  • 14548161321365 ()
010258

  • Denture reliner, soft, professional
GC RELINE™ II Cartridge ExtraExtraSoft: 1 x 55g(48mL)
Gc America Inc.
010257
In Commercial Distribution

  • 14548161321358 ()
010257

  • Denture reliner, soft, professional
GC RELINE II™ Intro Kit ExtraExtraSoft contains: 1 GC RELINE II cartridge ExtraExtraSoft 55g (48mL), 1 GC RELINE II Primer for Resin 8g (10mL), 1 GC RELINE II Point for Trimming, 1 GC Reline II Wheel for Finishing, 1 GC Reline II Remover for Resin 5g (5.5mL), 6 pieces Mixing Tip II L, 3 Disposable brushes, 1 Plastic spatula
Gc America Inc.
010256
In Commercial Distribution

  • 14548161321341 ()
010256

  • Denture reliner, soft, professional
60g KIT containing pink powder, liquid and sealer
The Myerson Company Limited
PSKIT-60-PNK
In Commercial Distribution

  • 00842326102002 ()


  • Denture reliner, soft, professional
60g KIT containing clear powder, liquid and sealer
The Myerson Company Limited
PSKIT-60-CLR
In Commercial Distribution

  • 00842326101999 ()


  • Denture reliner, soft, professional
LIQUID, 60ml
The Myerson Company Limited
PSLIQ-60
In Commercial Distribution

  • 00842326101982 ()


  • Denture reliner, soft, professional
SEALER, 30ml
The Myerson Company Limited
PSSEAL-30
In Commercial Distribution

  • 00842326101975 ()


  • Denture reliner, soft, professional
POWDER, CLEAR, 60g
The Myerson Company Limited
PSPOW-60-CLR
In Commercial Distribution

  • 00842326101968 ()


  • Denture reliner, soft, professional
POWDER, PINK, 60g
The Myerson Company Limited
PSPOW-60-PNK
In Commercial Distribution

  • 00842326101951 ()


  • Denture reliner, soft, professional
Hydro-Cast® Tissue Treatment 130g bottle Powder Only
Sultan Healthcare Inc
73020
In Commercial Distribution

  • D6870073020FG2 ()
  • D687730201 ()

  • Weight: 130 Gram


  • Denture reliner, soft, professional
Hydro-Cast® Tissue Treatment and Functional Impression Material 1x115mL Bottle Liquid
Sultan Healthcare Inc
73015
In Commercial Distribution

  • D6870073015FG2 ()
  • D687730151 ()

  • Total Volume: 115 Milliliter


  • Denture reliner, soft, professional
Hydro-Cast® Tissue Treatment and Functional Impression Material Standard Package 1x115mL Bottle Liquid, 1x130g Bottle Powder, 1x8mL Flow Replenisher
Sultan Healthcare Inc
73010
In Commercial Distribution

  • D6870073010FG2 ()
  • D687730101 ()

  • Total Volume: 8 Milliliter
  • Weight: 120 Gram
  • Total Volume: 115 Milliliter


  • Denture reliner, soft, professional
Henry Schein® Eugenol - 4 oz bottle
DENTSPLY INTERNATIONAL INC.
1710504FG
Not in Commercial Distribution

  • D6871710504FG2 ()
  • D6871710504FG0 ()

  • 12 Bottles (4 oz each)
  • Total Volume: 4 Fluid Ounce
1710504FG

  • Denture reliner, soft, professional
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