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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-dec - 10194665004491

Air HS Package,E679L,Expert Torque,OTC
A-DEC, INC.
54.0877.00
In Commercial Distribution

  • 10194665004491 ()
54.0877.00

  • Pneumatic dental power tool system handpiece tip, reusable

A-dec - 10194665004484

Air HS Package,M8700L,Master Torque,OTC
A-DEC, INC.
54.0876.00
In Commercial Distribution

  • 10194665004484 ()
54.0876.00

  • Pneumatic dental power tool system handpiece tip, reusable

A-dec - 10194665004477

Air HS Package,M8900L,Master Torque,OTC
A-DEC, INC.
54.0875.00
In Commercial Distribution

  • 10194665004477 ()
54.0875.00

  • Pneumatic dental power tool system handpiece tip, reusable

A-dec - 10194665004460

Electric LS Package,M20L,Master Matic,OTC
A-DEC, INC.
54.0865.00
In Commercial Distribution

  • 10194665004460 ()
54.0865.00

  • Barbed polyolefin suture

Pure&Clean - 00852421007515

Wound Solutions Wound Cleanser OTC 8 oz
Pure & Clean, LLC
2-25-20
In Commercial Distribution

  • 00852421007515 ()

  • Total Volume: 8 Fluid Ounce
11WC8-Z

  • Antimicrobial wound irrigation solution

Pure&Clean - 00852421007508

Wound Solutions Wound Cleanser OTC 2 oz
Pure & Clean, LLC
2-25-20
In Commercial Distribution

  • 00852421007508 ()

  • Total Volume: 2 Fluid Ounce
11WC2-Z

  • Antimicrobial wound irrigation solution

NoviMed Hearing - 00850049194457

Pro Rechargeable OTC Hearing Aids - Graphite Pair
Novidan, Inc.
99-0017-06
In Commercial Distribution

  • 00850049194457 ()


  • Air-conduction hearing aid, receiver-in-canal

NoviMed Hearing - 00850049194440

Pro Rechargeable OTC Hearing Aids - Beige Pair
Novidan, Inc.
99-0017-05
In Commercial Distribution

  • 00850049194440 ()


  • Air-conduction hearing aid, receiver-in-canal

NoviMed Hearing - 00850049194433

Pro Rechargeable OTC Hearing Aids - Glacier Pair
Novidan, Inc.
99-0017-04
In Commercial Distribution

  • 00850049194433 ()


  • Air-conduction hearing aid, receiver-in-canal

Novidan - 00850049194273

NoviOne BTE OTC Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0002-25
In Commercial Distribution

  • 00850049194273 ()


  • Air-conduction hearing aid, behind-the-ear

Novidan - 00850049194266

NoviOne BTE OTC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0002-24
In Commercial Distribution

  • 00850049194266 ()


  • Air-conduction hearing aid, behind-the-ear

Novidan - 00850049194259

NoviOne BTE OTC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0002-23
In Commercial Distribution

  • 00850049194259 ()


  • Air-conduction hearing aid, behind-the-ear

Novidan - 00850049194242

NoviOne RIC OTC Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0001-16
In Commercial Distribution

  • 00850049194242 ()


  • Air-conduction hearing aid, receiver-in-canal

Novidan - 00850049194235

NoviOne RIC OTC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0001-15
In Commercial Distribution

  • 00850049194235 ()


  • Air-conduction hearing aid, receiver-in-canal

Novidan - 00850049194228

NoviOne RIC OTC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0001-14
In Commercial Distribution

  • 00850049194228 ()


  • Air-conduction hearing aid, receiver-in-canal

NoviMed Hearing - 00850049194211

Pro OTC RIC Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0007-06
In Commercial Distribution

  • 00850049194211 ()


  • Air-conduction hearing aid, receiver-in-canal

NoviMed Hearing - 00850049194204

Pro OTC RIC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0007-05
In Commercial Distribution

  • 00850049194204 ()


  • Air-conduction hearing aid, receiver-in-canal

NoviMed Hearing - 00850049194198

Pro OTC RIC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0007-04
In Commercial Distribution

  • 00850049194198 ()


  • Air-conduction hearing aid, receiver-in-canal

Sonify Hearing - 00850049194181

Mach I Pro OTC Hearing Aids - Charcoal
Novidan, Inc.
99-0006-08
In Commercial Distribution

  • 00850049194181 ()


  • Air-conduction hearing aid, receiver-in-canal

Remington - 00074590552560

Intense pulse light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL7000
In Commercial Distribution

  • 10074590552567 ()
  • 00074590552560 ()


  • Intense pulsed light skin surface treatment system

Remington - 00074590546033

Intense Pulse Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL2500USA
In Commercial Distribution

  • 10074590546030 ()
  • 00074590546033 ()


  • Intense pulsed light skin surface treatment system

Remington - 00074590544503

Intense Pulse Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL7510
In Commercial Distribution

  • 00074590544503 ()
  • 10074590544500 ()


  • Intense pulsed light skin surface treatment system

Remington Products - 00074590544268

Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6500QFB
In Commercial Distribution

  • 10074590544265 ()
  • 00074590544268 ()


  • Intense pulsed light skin surface treatment system

Luma Rx - 00074590543131

Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6800R
In Commercial Distribution

  • 10074590543138 ()
  • 00074590543131 ()


  • Intense pulsed light skin surface treatment system

Remington Products - 00074590542974

Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6000Q-R
In Commercial Distribution

  • 10074590542971 ()
  • 00074590542974 ()


  • Intense pulsed light skin surface treatment system

Luma Rx - 00074590540345

Intense Pulsed Light OTC Hair Removal Device
SPECTRUM BRANDS, INC.
IPL6800USA
In Commercial Distribution

  • 10074590540342 ()
  • 00074590540345 ()


  • Intense pulsed light skin surface treatment system

Remington - 00074590535471

Intense Pulse Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL2000USA
In Commercial Distribution

  • 10074590535478 ()
  • 00074590535471 ()


  • Intense pulsed light skin surface treatment system

Remington Products - 00074590530407

Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6000Q
In Commercial Distribution

  • 10074590530404 ()
  • 00074590530407 ()


  • Intense pulsed light skin surface treatment system

Remington Products - 00074590512175

Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6000USA
In Commercial Distribution

  • 10074590512172 ()
  • 00074590512175 ()


  • Intense pulsed light skin surface treatment system

RCA - 00044476153280

OTC hearing aids, behind-the-ear design, one pair
Voxx Accessories Corp.
RSH052BK
In Commercial Distribution

  • 00044476153280 ()


  • Air-conduction hearing aid, behind-the-ear

RCA - 00044476153273

OTC hearing aids, behind-the-ear design, one pair
Voxx Accessories Corp.
RSH052GY
In Commercial Distribution

  • 00044476153273 ()


  • Air-conduction hearing aid, behind-the-ear

RCA - 00044476153266

OTC hearing aids, behind-the-ear design, one pair
Voxx Accessories Corp.
RSH052BG
In Commercial Distribution

  • 00044476153266 ()


  • Air-conduction hearing aid, behind-the-ear

RCA - 00044476153198

OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20WH
In Commercial Distribution

  • 00044476153198 ()


  • Air-conduction hearing aid, in-the-ear

RCA - 00044476153181

OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20GYW
In Commercial Distribution

  • 00044476153181 ()


  • Air-conduction hearing aid, in-the-ear

RCA - 00044476153174

OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20BGW
In Commercial Distribution

  • 00044476153174 ()


  • Air-conduction hearing aid, in-the-ear

DRX-Compass X-ray System - 60889978624768

XRAY OTC 80KW 400KHU AUTOTILT CF OSHPD
CARESTREAM HEALTH, INC.
DRX-Compass X-ray System
In Commercial Distribution

  • 60889978624768 ()
8624769

  • Stationary basic diagnostic x-ray system, digital

Medical Trauma Kit Individual Trauma Kit OTC - M689SDRVSIPOTC010

1 - TMT-Tourniquet 1 - Celox RAPID B-Con 1 - Positional Airway Card 2 - Sentinel Chest Seal 1 - Emergency Bandage 1 - Blizzard IFAK Blanket 2 - Exam Gloves 1 - Quick Reference Guide
Safeguard US Operating, LLC
1
In Commercial Distribution

  • M689SDRVSIPOTC010 ()
SDR-VSIP-OTC

  • First aid kit, non-medicated, single-use

Mobility+ OTC Enteral Feeding Device 440 mm - 05391537090127

The Mobility+ Enteral Feeding System (“Mobility+ System”) is a portable, lightweight, non-electronic, disposable enteral feeding system intended to deliver commercially available liquid nutrition formula to a patient, using a standard extension set (or feeding tube) with an ENFit® connector, in the clinical or home care settings.
ROCKFIELD MEDICAL DEVICES LIMITED
MOB2-0440
In Commercial Distribution

  • 05391537090165 ()
  • 05391537090127 ()
  • 05391537090202 ()
  • 05391537090240 ()
  • 05391537090288 ()
  • 05391537090325 ()

  • Length: 440 Millimeter
MOB2-0440-30, MOB2-0440-03, MOB2-0440-03-09, MOB2-0440-10, MOB2-0440-10-03

  • Enteral feeding noninvasive-component set

WoundClot Hemostatic Gauze - 07290016339413

WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
3"X23.6" OTC FDA
In Commercial Distribution

  • 17290016339410 ()
  • 07290016339413 ()
101586901

  • Plant polysaccharide haemostatic agent, bioabsorbable

WoundClot Hemostatic Gauze - 07290016339406

WoundClot is a soluble dressing, based on cellulosic structure. In contact with liquids it forms absorbent gel which adheres to the wound surface to control bleeding. WoundClot is intended to be used as a topical dressing for minor skin surface bleeding wounds such as minor cuts and minor abrasions.
CORE SCIENTIFIC CREATIONS LTD
3"X8" OTC FDA
In Commercial Distribution

  • 17290016339403 ()
  • 07290016339406 ()
101582901

  • Plant polysaccharide haemostatic agent, bioabsorbable
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