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

  • 00850049194273 ()


  • Air-conduction hearing aid, behind-the-ear
NoviOne BTE OTC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0002-24
In Commercial Distribution

  • 00850049194266 ()


  • Air-conduction hearing aid, behind-the-ear
NoviOne BTE OTC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0002-23
In Commercial Distribution

  • 00850049194259 ()


  • Air-conduction hearing aid, behind-the-ear
NoviOne RIC OTC Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0001-16
In Commercial Distribution

  • 00850049194242 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC OTC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0001-15
In Commercial Distribution

  • 00850049194235 ()


  • Air-conduction hearing aid, receiver-in-canal
NoviOne RIC OTC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0001-14
In Commercial Distribution

  • 00850049194228 ()


  • Air-conduction hearing aid, receiver-in-canal
Pro OTC RIC Hearing Aids, Pair - Charcoal
Novidan, Inc.
99-0007-06
In Commercial Distribution

  • 00850049194211 ()


  • Air-conduction hearing aid, receiver-in-canal
Pro OTC RIC Hearing Aids, Pair - Slate
Novidan, Inc.
99-0007-05
In Commercial Distribution

  • 00850049194204 ()


  • Air-conduction hearing aid, receiver-in-canal
Pro OTC RIC Hearing Aids, Pair - Beige
Novidan, Inc.
99-0007-04
In Commercial Distribution

  • 00850049194198 ()


  • Air-conduction hearing aid, receiver-in-canal
Mach I Pro OTC Hearing Aids - Charcoal
Novidan, Inc.
99-0006-08
In Commercial Distribution

  • 00850049194181 ()


  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen OTC Hearing Aids - Beige Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Beige
In Commercial Distribution

  • 00850022464157 ()
LLO00003BE

  • Air-conduction hearing aid, receiver-in-canal
Lexie Lumen OTC Hearing Aids - Gray Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Gray
In Commercial Distribution

  • 00850022464065 ()
LLO00001GR

  • Air-conduction hearing aid, receiver-in-canal
Tala Charger for Tala OTC Hearing Aid
ETYMOTIC RESEARCH, INC.
TALA CHARGER
In Commercial Distribution

  • 00846430005860 ()


  • Air-conduction hearing aid, in-the-ear
QuikClot Bleeding Control Kit, Stanford, OTC, CAT
Z-MEDICA, LLC
0613
In Commercial Distribution

  • 00841495106132 ()
0613

  • Non-organic haemostatic agent
OTC, HEARING AID, BEHIND EAR, BT, WT
MEDLINE INDUSTRIES, INC.
MDSHEARAIDWT2
In Commercial Distribution

  • 00197344013282 ()

  • MDSHEARAIDWT
  • Width: 10.5 Millimeter
  • Length: 33.1 Millimeter
MDSHEARAIDWT2

  • Air-conduction hearing aid, behind-the-ear
OTC, HEARING AID, IN EAR, BT, BLACK
MEDLINE INDUSTRIES, INC.
MDSHEARAIDBK2
In Commercial Distribution

  • 20197344013255 ()
  • 00197344013251 ()
MDSHEARAIDBK2

  • Air-conduction hearing aid, in-the-ear
Intense pulse light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL7000
In Commercial Distribution

  • 10074590552567 ()
  • 00074590552560 ()


  • Intense pulsed light skin surface treatment system
Intense Pulse Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL2500USA
In Commercial Distribution

  • 10074590546030 ()
  • 00074590546033 ()


  • Intense pulsed light skin surface treatment system
Intense Pulse Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL7510
In Commercial Distribution

  • 00074590544503 ()
  • 10074590544500 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6500QFB
In Commercial Distribution

  • 10074590544265 ()
  • 00074590544268 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6800R
In Commercial Distribution

  • 10074590543138 ()
  • 00074590543131 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6000Q-R
In Commercial Distribution

  • 10074590542971 ()
  • 00074590542974 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC Hair Removal Device
SPECTRUM BRANDS, INC.
IPL6800USA
In Commercial Distribution

  • 10074590540342 ()
  • 00074590540345 ()


  • Intense pulsed light skin surface treatment system
Intense Pulse Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL2000USA
In Commercial Distribution

  • 10074590535478 ()
  • 00074590535471 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6000Q
In Commercial Distribution

  • 10074590530404 ()
  • 00074590530407 ()


  • Intense pulsed light skin surface treatment system
Intense Pulsed Light OTC hair removal device
SPECTRUM BRANDS, INC.
IPL6000USA
In Commercial Distribution

  • 10074590512172 ()
  • 00074590512175 ()


  • Intense pulsed light skin surface treatment system
OTC hearing aids, behind-the-ear design, one pair
Voxx Accessories Corp.
RSH052BK
In Commercial Distribution

  • 00044476153280 ()


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

  • 00044476153273 ()


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

  • 00044476153266 ()


  • Air-conduction hearing aid, behind-the-ear
OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20WH
In Commercial Distribution

  • 00044476153198 ()


  • Air-conduction hearing aid, in-the-ear
OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20GYW
In Commercial Distribution

  • 00044476153181 ()


  • Air-conduction hearing aid, in-the-ear
OTC hearing aids, with battery display case
Voxx Accessories Corp.
RSH20BGW
In Commercial Distribution

  • 00044476153174 ()


  • Air-conduction hearing aid, in-the-ear
Procellera Single Layer OTC, 4"x 4"
Vomaris Wound Care, Inc.
4" x 4"
In Commercial Distribution

  • 00810198030389 ()
VSC-0404

  • Bioelectric wound dressing
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
Engage Android OTC Rechargeable Grey Replacement Right
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831870 ()
10098-R REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Rechargeable Grey Replacement Left
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831863 ()
10098-L REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Rechargeable Grey Replacement Right
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831856 ()
10097-R REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage MFI OTC Rechargeable Grey Replacement Left
HEARING LAB TECHNOLOGY, LLC
7595
In Commercial Distribution

  • 00810068831849 ()
10097-L REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Rechargeable Black Replacement Right
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831832 ()
10096-R REPLACE

  • Air-conduction hearing aid, receiver-in-the-ear
Engage Android OTC Rechargeable Black Replacement Left
HEARING LAB TECHNOLOGY, LLC
7495
In Commercial Distribution

  • 00810068831825 ()
10096-L REPLACE

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