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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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UNIFAST™ - D6583382031

UNIFAST™ LC Translucent, 50g powder
Gc America Inc.
338203
In Commercial Distribution

  • D6583382032 ()
  • D6583382031 ()
338203

  • Temporary dental crown/bridge resin

EXAFLEX® - D6581389011

EXAFLEX® Regular (blue) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
Gc America Inc.
138901
In Commercial Distribution

  • D6581389012 ()
  • D6581389011 ()
138901

  • Silicone dental impression material

EXAFLEX® - D6581384011

EXAFLEX® Monophase (purple) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
Gc America Inc.
138401
In Commercial Distribution

  • D6581384012 ()
  • D6581384011 ()
138401

  • Silicone dental impression material

EXAFLEX® - D6581383011

EXAFLEX® Putty 1-1 Pack (1 x 500g blue base Jar, 1 x 500g yellow catalyst Jar, 2 x scoops)
Gc America Inc.
138301
In Commercial Distribution

  • D6581383012 ()
  • D6581383011 ()
138301

  • Silicone dental impression material

EXAFLEX® - D6581381011

EXAFLEX® Injection (pink) Standard Packs (1 x 74mL base, 1 x 74mL catalyst, 1 x mixing pad)
Gc America Inc.
138101
In Commercial Distribution

  • D6581381012 ()
  • D6581381011 ()
138101

  • Silicone dental impression material

EXAlence™ - D6581374441

EXA’lence™ Regular Set 48mL Cartridge Medium Body (Purple), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137444
In Commercial Distribution

  • D6581374442 ()
  • D6581374441 ()
137444

  • Silicone dental impression material

EXAFAST™ - D6581374071

EXAFAST™ NDS Monophase (purple) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137407
In Commercial Distribution

  • D6581374072 ()
  • D6581374071 ()
137407

  • Silicone dental impression material

EXAMIX™ - D6581374061

EXAMIX™ NDS Monophase (purple) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137406
In Commercial Distribution

  • D6581374062 ()
  • D6581374061 ()
137406

  • Silicone dental impression material

EXAlence™ - D6581373341

EXA’lence™ Regular Set 48mL Cartridge Light Body (Pink), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137334
In Commercial Distribution

  • D6581373342 ()
  • D6581373341 ()
137334

  • Silicone dental impression material

EXAlence™ - D6581373041

EXA’lence™ Fast Set 48mL Cartridge Light Body (Pink), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137304
In Commercial Distribution

  • D6581373042 ()
  • D6581373041 ()
137304

  • Silicone dental impression material

OMNIFLEX™ - D6581373011

OMNIFLEX™ Standard Set (1 x 90mL base, 1 x 45mL catalyst, 1 x 15mL adhesive)
Gc America Inc.
137301
In Commercial Distribution

  • D6581373012 ()
  • D6581373011 ()
137301

  • Polyether dental impression material

EXAlence™ - D6581372041

EXA’lence™ Fast Set 48mL Cartridge Extra Light Body (Yellow), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137204
In Commercial Distribution

  • D6581372042 ()
  • D6581372041 ()
137204

  • Silicone dental impression material

EXAFAST™ - D6581371071

EXAFAST™ NDS Injection (copper) Two Packs (2 x 48mL cartridges, 6 x mixing tips)
Gc America Inc.
137107
In Commercial Distribution

  • D6581371072 ()
  • D6581371071 ()
137107

  • Silicone dental impression material

EXAlence™ - D6581371041

EXA’lence™ Fast Set 48mL Cartridge Heavy Rigid Body (Green), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137104
In Commercial Distribution

  • D6581371042 ()
  • D6581371041 ()
137104

  • Silicone dental impression material

EXAlence™ - D6581370041

EXA’lence™ Regular Set 48mL Cartridge Heavy Body (Dark Green), 4 x cartridges, 12 x mixing tips
Gc America Inc.
137004
In Commercial Distribution

  • D6581370042 ()
  • D6581370041 ()

  • Total Volume: 48 Milliliter
137004

  • Silicone dental impression material

COE-FLO™ - D6581340011

COE-FLO™ Standard Package (1 x 110g base, 1 x 115g catalyst)
Gc America Inc.
134001
Not in Commercial Distribution

  • D6581340012 ()
  • D6581340011 ()
134001

  • Denture reliner, soft, professional

COE-FLEX® - D6581310031

COE-FLEX® Standard Package Injection Type (1 x 90mL base, 1 x 45mL catalyst, 1 x 13mL adhesive)
Gc America Inc.
131003
In Commercial Distribution

  • D6581310032 ()
  • D6581310031 ()
131003

  • Polyether dental impression material

COE HYDROPHILIC GEL™ - D6581241011

COE HYDROPHILIC GEL™ Fast set, cherry, 1 x 1lb powder and 1 x scoop
Gc America Inc.
124101
In Commercial Distribution

  • D6581241012 ()
  • D6581241011 ()

  • Weight: 1 Pound
124101

  • Silicone dental impression material

COE ALGINATE™ - D6581200011

COE ALGINATE™ Normal set, mint, 1 x 1lb powder and 1 x scoop
Gc America Inc.
120001
In Commercial Distribution

  • D6581200012 ()
  • D6581200011 ()

  • Weight: 1 Pound
120001

  • Silicone dental impression material

CLEARinse Nasal Aspirator - CRBFV2

No Description
PENO LLC
CR-BF
In Commercial Distribution

  • B423BF12714T16D2020051 ()
  • CRBFV2 ()


  • Nasal aspirator, electric

Aligned Medical Solutions - BO98AMS9083E0

Vital Cath Pack
Aligned Medical Solutions
AMS9083E
In Commercial Distribution

  • B098AMS9083E1 ()
  • BO98AMS9083E0 ()
AMS9083E

  • Cardiothoracic surgical procedure kit, non-medicated, single-use

Aligned Medical Solutions - BO98AMS6572B0

Breast Biopsy Pack (24771)
Aligned Medical Solutions
AMS6572B
In Commercial Distribution

  • B098AMS6572B1 ()
  • BO98AMS6572B0 ()
AMS6572B

  • General surgical procedure kit, medicated

BlackBox - B963WS501C0

Cellular weight scale with a large platform and high weight capacity
Blackbox Remote Patient Monitoring LLC
WS-501C
In Commercial Distribution

  • BB4B963WS501C1 ()
  • B963WS501C0 ()


  • Stand-on floor scale, electronic

BlackBox RPM - B963PO401W1

Pulse Oximeter
Blackbox Remote Patient Monitoring LLC
PO-401W
In Commercial Distribution

  • BB4B963PO401W1 ()
  • B963PO401W1 ()


  • Pulse oximeter

BlackBox RPM - B963BPM201W1

Blood Pressure monitor designed to be used seamlessly with our proprietary hub or mobile app.
Blackbox Remote Patient Monitoring LLC
BPM-201W
Not in Commercial Distribution

  • B963BPM201W1 ()
  • BB1BB963201W1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

BlackBox RPM - B963102C1

Cellular Blood Pressure monitor
Blackbox Remote Patient Monitoring LLC
BPM-102C
In Commercial Distribution

  • B963102C1 ()
  • B963BB10BPM102C10 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

BlackBox - B963101C1

Cellular Blood Pressure Monitor
Blackbox Remote Patient Monitoring LLC
BPM-101C
In Commercial Distribution

  • B963101C1 ()
  • BB1BB963101C1 ()


  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

Indiana Face Mask - B959IFMSM30

ASTM Level 3 Surgical Mask
Fssc LLC
IFM-SM3
In Commercial Distribution

  • B959IFMSM31 ()
  • B959IFMSM30 ()
  • B959IFMSM300 ()


  • Surgical/medical face mask, non-antimicrobial, single-use

Domia Front - B937DOF2080

Dormia 2Fr 8mm Stone Extractor
EPflex Feinwerktechnik GmbH.
DOF208
In Commercial Distribution

  • B937DOF2081 ()
  • B937DOF2080 ()
DOF208

  • Urinary stone retrieval basket, single-use

Domia Front - B937DOF2010

Dormia 2Fr 11mm Stone Extractor
EPflex Feinwerktechnik GmbH.
DOF201
In Commercial Distribution

  • B937DOF2011 ()
  • B937DOF2010 ()
DOF201

  • Urinary stone retrieval basket, single-use

Domia Front - B937DOF1580

Dormia 1.5Fr.8mm Stone Extractor
EPflex Feinwerktechnik GmbH.
DOF158
In Commercial Distribution

  • B937DOF1581 ()
  • B937DOF1580 ()
DOF158

  • Urinary stone retrieval basket, single-use

Domia Front - B937DOF1510

Dormia 1.5Fr 11mm Stone Extractor
EPflex Feinwerktechnik GmbH.
DOF151
In Commercial Distribution

  • B937DOF1511 ()
  • B937DOF1510 ()
DOF151

  • Urinary stone retrieval basket, single-use

DATEX-OHMEDA - B929OMA86520

1009-3036-000/ M91-4 PVT LABEL
WESTERN/SCOTT FETZER COMPANY
OMA-8652
In Commercial Distribution

  • B929OMA86520 ()
  • B929OMA86521 ()
OMA-8652

  • Pin-indexed adaptor, reusable

EcoGuard® Surgical Mask - B927FA00111

A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.
Ecoguard, Inc
EcoGuard B
In Commercial Distribution

  • B927FA00112 ()
  • B927FA00111 ()
  • B927FA00110 ()


  • Surgical/medical face mask, single-use

CROWN SURGICAL - B924193500

ADSON Tissue Forceps, 1 x 2 teeth, 4-3/4"
CROWN SURGICAL CORPORATION
FORCEPS
In Commercial Distribution

  • B924193501 ()
  • B924193500 ()
  • B924193502 ()
19-350

  • Dressing/utility forceps, scissors-like, single-use

CROWN SURGICAL - B92419349PP0

ADSON Dressing Forceps, Serrated, 4-3/4" PP
CROWN SURGICAL CORPORATION
FORCEPS
In Commercial Distribution

  • B92419349PP2 ()
  • B92419349PP0 ()
  • B92419349PP1 ()
19-349-PP

  • Dressing/utility forceps, scissors-like, single-use

CROWN SURGICAL - B924193490

ADSON Dressing Forceps, Serrated, 4-3/4"
CROWN SURGICAL CORPORATION
FORCEPS
In Commercial Distribution

  • B924193491 ()
  • B924193490 ()
  • B924193492 ()
19-349

  • Dressing/utility forceps, scissors-like, single-use

CROWN SURGICAL - B924162900

MAYO-HEGAR Needle Holder, 8"
CROWN SURGICAL CORPORATION
NEEDLE HOLDER
In Commercial Distribution

  • B924162901 ()
  • B924162900 ()
  • B924162902 ()
16-290

  • Suturing needle holder, single-use

CROWN SURGICAL - B924162880

MAYO-HEGAR Needle Holder, 7"
CROWN SURGICAL CORPORATION
NEEDLE HOLDER
In Commercial Distribution

  • B924162881 ()
  • B924162880 ()
  • B924162882 ()
16-288

  • Suturing needle holder, single-use

CROWN SURGICAL - B92416287SM0

MAYO-HEGAR Needle Holder, 6" SMOOTH
CROWN SURGICAL CORPORATION
NEEDLE HOLDER
In Commercial Distribution

  • B92416287SM1 ()
  • B92416287SM0 ()
  • B92416287SM2 ()
16-287-SM

  • Suturing needle holder, single-use
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