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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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A. Titan Instruments - 00841685110062

Straight, 5mm, Red, D-Lux Elevator
A. TITAN INSTRUMENTS, INC.
Lux 5
In Commercial Distribution

  • 00841685110062 ()


  • Dental elevator, tooth/root

A. Titan Instruments - 00841685109530

Explorer, Double Ended
A. TITAN INSTRUMENTS, INC.
Expl 5
In Commercial Distribution

  • 00841685109530 ()


  • Dental surgical probe, reusable

Allia - 00195278719263

Allia IGS5 UDI
GE MEDICAL SYSTEMS
IGS 5
In Commercial Distribution

  • 00195278719263 ()
5943307

  • Stationary angiographic x-ray system, digital

Allia - 00195278485144

Allia IGS5 UDI
GE MEDICAL SYSTEMS
IGS 5
In Commercial Distribution

  • 00195278485144 ()
5872892

  • Stationary angiographic x-ray system, digital

MyCRO Band - 04064409000074

MyCRO Band w/Lining blue
OTTO BOCK HEALTHCARE
24H1=5
In Commercial Distribution

  • 04064409000074 ()


  • Cranial orthosis

Sterile Water for Inhalation, USP, 5 mL UDV - 00376204500050

No Description
RITEDOSE PHARMACEUTICALS, LLC
5 mL
In Commercial Distribution

  • 00376204500050 ()
  • 00376204500999 ()


  • Inhalation therapy sterile water

Sodium Chloride Inhalation Solution, USP, 0.45% 5 mL UDV - 00376204400053

No Description
RITEDOSE PHARMACEUTICALS, LLC
5 mL
In Commercial Distribution

  • 00376204400053 ()
  • 00376204400992 ()


  • Inhalation therapy saline solution, isotonic

Sodium Chloride Inhalation Solution, USP, 0.9% 5 mL UDV - 00376204300056

No Description
RITEDOSE PHARMACEUTICALS, LLC
5 mL
In Commercial Distribution

  • 00376204300056 ()
  • 00376204300995 ()


  • Inhalation therapy saline solution, isotonic

Sodium Chloride Inhalation Solution, USP, 0.9% 3 mL UDV individually wrapped - 00376204300018

One vial per foil pouch
RITEDOSE PHARMACEUTICALS, LLC
5 mL
In Commercial Distribution

  • 00376204300018 ()
  • 00376204300964 ()


  • Inhalation therapy saline solution, isotonic

American Eagle Instruments - 00841013109324

No Description
AMERICAN EAGLE INSTRUMENTS, INC.
AEOVSWV8/5
In Commercial Distribution

  • 00841013109324 ()


  • Instrument tray, reusable

S5 Shelf with AC Outlet Strip - 04033817901402

No Description
LivaNova Deutschland GmbH
5 pos.
In Commercial Distribution

  • 04033817901402 ()


  • Cardiopulmonary bypass system, roller type

S5 Shelf without AC Outlet Strip - 04033817901396

No Description
LivaNova Deutschland GmbH
5 pos.
In Commercial Distribution

  • 04033817901396 ()


  • Cardiopulmonary bypass system, roller type

Proform Hip System - 10840843100034

No Description
GLOBUS MEDICAL, INC.
SC1151-28MM -5
In Commercial Distribution

  • 10840843100034 ()


  • Metallic femoral head prosthesis

StelKast Generic Hip instruments - 10840843127789

Trial Femoral Head Assembly, 28MM -5
GLOBUS MEDICAL, INC.
SC4060-28 -5
In Commercial Distribution

  • 10840843127789 ()


  • Femoral head prosthesis trial

StelKast Generic Hip instruments - 10840843127277

Trial Femoral Head Assembly, 28 MM -5
GLOBUS MEDICAL, INC.
SC2120-28 -5
In Commercial Distribution

  • 10840843127277 ()


  • Femoral head prosthesis trial

Vitallium® - D001N0017000

No Description
Dentsply International Inc.
5 Alloy
Not in Commercial Distribution

  • D001N0017000 ()

  • Weight: 1 Kilogram
N001700

  • Dental casting non-noble alloy

V.A.C. WHITEFOAM™ - 00849554000810

VAC Whitefoam Dressing Large Featuring Sensatrac Technology
KCI USA, INC.
M8275067/5
In Commercial Distribution

  • 00849554000810 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

V.A.C. WHITEFOAM™ - 00849554000797

VAC Whitefoam Dressing Small Featuring Sensatrac Technology
KCI USA, INC.
M8275068/5
In Commercial Distribution

  • 00849554000797 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

Hybrid Dressing - 00849405001706

Hybrid Dressing 10x30 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drapes. The three components are packaged together.
GENADYNE BIOTECHNOLOGIES INC.
UP-D1030/5
In Commercial Distribution

  • 00849405001706 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

Hybrid Dressing - 00849405001690

Hybrid Dressing 10x50 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drapes. The three components are packaged together.
GENADYNE BIOTECHNOLOGIES INC.
UP-D1050/5
In Commercial Distribution

  • 00849405001690 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

Hybrid Dressing - 00849405001683

Hybrid Dressing 15x20 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drapes. The three components are packaged together.
GENADYNE BIOTECHNOLOGIES INC.
UP-D1520/5
In Commercial Distribution

  • 00849405001683 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

Hybrid Dressing - 00849405001676

Hybrid Dressing 15x30 cm. Case of 5. Each Hybrid Dressing Kit consist of foam dressing with a hole, port film dressing and drapes. The three components are packaged together.
GENADYNE BIOTECHNOLOGIES INC.
UP-D1530/5
In Commercial Distribution

  • 00849405001676 ()


  • Negative-pressure wound therapy system foam dressing, non-antimicrobial

LUMINDEX - 04719873921461

LUMINDEX 5 (US)
DENTMATE TECHNOLOGY CO., LTD.
LUMINDEX 5
In Commercial Distribution

  • 04719873921461 ()


  • Fixed examination/treatment room light

Ultra-Lite - 04713909450505

No Description
ROLENCE ENTERPRISE INC.
5 Turbo
Not in Commercial Distribution

  • 04713909450505 ()


  • Dental/surgical polymerization lamp

IMAGEnet 5 OPHTHALMIC DATA SYSTEM - 04562123288308

No Description
TOPCON CORPORATION
IMAGEnet 5
In Commercial Distribution

  • 04562123288308 ()


  • Camera application software

Visionix - 04580606431676

Bear Chart SET
RIGHT MFG. CO., LTD.
Retinomax 5
In Commercial Distribution

  • 04580606431676 ()
VSN5100BB

  • Automated ophthalmic refractometer

Visionix - 04580606431669

Fireworks Chart SET
RIGHT MFG. CO., LTD.
Retinomax 5
In Commercial Distribution

  • 04580606431669 ()
VSN5100FB

  • Automated ophthalmic refractometer

Visionix - 04580606431652

Tulip Chart SET
RIGHT MFG. CO., LTD.
Retinomax 5
In Commercial Distribution

  • 04580606431652 ()
VSN5100TB

  • Automated ophthalmic refractometer

Righton - 04580606430426

Bear SET with Carrying case
RIGHT MFG. CO., LTD.
Retinomax 5
Not in Commercial Distribution

  • 04580606430426 ()
RDA2132BA

  • Automated ophthalmic refractometer

Righton - 04580606430372

Fireworks SET with Carrying case
RIGHT MFG. CO., LTD.
Retinomax 5
Not in Commercial Distribution

  • 04580606430372 ()
RDA2142BA

  • Automated ophthalmic refractometer

Righton - 04580606430327

Tulip Chart SET with Carrying case
RIGHT MFG. CO., LTD.
Retinomax 5
Not in Commercial Distribution

  • 04580606430327 ()
RDA2112BA

  • Automated ophthalmic refractometer

Righton - 04580606430129

Bear Chart SET
RIGHT MFG. CO., LTD.
Retinomax 5
Not in Commercial Distribution

  • 04580606430129 ()
RDA2132AA

  • Automated ophthalmic refractometer

Righton - 04580606430075

Fireworks Chart SET
RIGHT MFG. CO., LTD.
Retinomax 5
Not in Commercial Distribution

  • 04580606430075 ()
RDA2142AA

  • Automated ophthalmic refractometer

Righton - 04580606430020

Tulip Chart SET
RIGHT MFG. CO., LTD.
Retinomax 5
Not in Commercial Distribution

  • 04580606430020 ()
RDA2112AA

  • Automated ophthalmic refractometer

G&H HIGH PULL HEADCAP - 10190886000274

HIGH PULL HEADCAP SMALL
G & H Wire Company, Inc.
HPS**5
In Commercial Distribution

  • 10190886000274 ()
  • 00190886000277 ()


  • Orthodontic extraoral headgear

G&H HIGH PULL HEADCAP - 10190886000250

LARGE
G & H Wire Company, Inc.
HPL**5
In Commercial Distribution

  • 10190886000250 ()
  • 00190886000253 ()


  • Orthodontic extraoral headgear

Scribe OpCo - 00850013750221

No Description
Scribe Opco, Inc.
Kit 5
In Commercial Distribution

  • 00850013750221 ()


  • First aid kit, medicated

Hybrid Lubricant - 00850014621780

Hybrid Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
5 mL
In Commercial Distribution

  • 30850014621781 ()
  • 00850014621780 ()
  • 00850044065042 ()
200501

  • Sexual lubricant

Liquid Lubricant - 00850014621773

Liquid Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
5 mL
In Commercial Distribution

  • 30850014621774 ()
  • 00850014621773 ()
  • 00850044065035 ()
200500

  • Sexual lubricant

BioNourish Vaginal Gel - 00850014621070

BioNourish Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
GOOD CLEAN LOVE, INC.
5 mL
In Commercial Distribution

  • 30850014621071 ()
  • 00850014621070 ()
  • 00850044065028 ()
  • 00850044065127 ()
200601

  • Sexual lubricant
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