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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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COMFORTFULL 2 MASK with SE, SMALL, CHINA
Respironics, Inc.
COMFORTFULL 2 MASK with SE, SMALL, CHINA
Not in Commercial Distribution

  • 00606959041813 ()
CN1023747

  • CPAP/BPAP face mask, reusable
COMFORTFULL 2 Mask with Headgear, Large, China
Respironics, Inc.
COMFORTFULL 2 Mask with Headgear, Large, China
Not in Commercial Distribution

  • 00606959041806 ()
CN1004951

  • CPAP/BPAP face mask, reusable
COMFORTFULL 2 Mask with Headgear, Reusable, Small, China
Respironics, Inc.
COMFORTFULL 2 Mask with Headgear, Reusable, Small, China
Not in Commercial Distribution

  • 00606959041790 ()
CN1004881

  • CPAP/BPAP face mask, reusable
COMFORTFULL 2 Mask with Headgear, Reusable, Medium, China
Respironics, Inc.
COMFORTFULL 2 Mask with Headgear, Reusable, Medium, China
Not in Commercial Distribution

  • 00606959041783 ()
CN1004873

  • CPAP/BPAP face mask, reusable
Actiwatch 2 Docking Station
Respironics, Inc.
Actiwatch 2 Docking Station
In Commercial Distribution

  • 00606959042056 ()
1046977

  • Kinesiology ambulatory recorder
Handpiece Maintenance Unit
J.MORITA MFG.CORP.
HIM-2-BA
In Commercial Distribution

  • 04548213049899 ()


  • Dental handpiece maintenance unit
Handpiece Maintenance Unit
J.MORITA MFG.CORP.
HIM-2-EX1
In Commercial Distribution

  • 04548213044788 ()


  • Dental handpiece maintenance unit
An elastic bandage device consisting of a long flat strip of elasticized non-latex cohesive material that is used as a wrap to support and compress a part of a patient's body.
Medique Products
6901
Not in Commercial Distribution

  • 50347682609011 ()
  • 00347682609016 ()
6901

  • Skin treatment/dressing-supportive limb/finger bandage, single-use
DOSE2 Reference Class Therapy dosimeter Standardversion
IBA Dosimetry GmbH
E1302000
In Commercial Distribution

  • EIBAE13020000 ()


  • Radiation electrometer
ELASTEX 2 X LARGE
HENRY SCHEIN, INC.
1127027
In Commercial Distribution

  • 10304040040307 ()
  • 00304040040300 ()
  • 20304040040304 ()
1127027

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
ELASTEX 2 LARGE
HENRY SCHEIN, INC.
1127026
In Commercial Distribution

  • 10304040040291 ()
  • 00304040040294 ()
  • 20304040040298 ()
1127026

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
ELASTEX 2 MEDIUM
HENRY SCHEIN, INC.
1127025
In Commercial Distribution

  • 10304040040284 ()
  • 00304040040287 ()
  • 20304040040281 ()
1127025

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
ELASTEX 2 X SMALL
HENRY SCHEIN, INC.
1127023
In Commercial Distribution

  • 10304040040277 ()
  • 00304040040270 ()
  • 20304040040274 ()
1127023

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
ELASTEX 2 SMALL
HENRY SCHEIN, INC.
1127024
In Commercial Distribution

  • 10304040040260 ()
  • 00304040040263 ()
  • 20304040040267 ()
1127024

  • Nitrile examination/treatment glove, non-powdered, non-antimicrobial
N/A
Carl Zeiss Vision GmbH
000000-2408-310
In Commercial Distribution

  • 04250668606717 ()
000000-2408-310

  • Vision corrective spectacles centration image analysis software
N/A
Carl Zeiss Vision GmbH
000000-1898-991
In Commercial Distribution

  • 04250668606694 ()
000000-1898-991

  • Ophthalmodiastimeter
MaxFOV 2 Application Container for Smart Subscription
Hangwei GE Medical Systems Co., Ltd.
1.0
In Commercial Distribution

  • 00195278363947 ()


  • Full-body CT system
Removable needle, non-sterile reusable injector.
OWEN MUMFORD LIMITED
AJ1311
In Commercial Distribution

  • 00384701311017 ()
  • 0384701311031 ()

  • Width: 25 Micrometer
  • Length: 220 Millimeter
AJ1311

  • Syringe-loaded medication/vaccine injector, manual, professional
Fixed needle, non-sterile reusable injector.
OWEN MUMFORD LIMITED
AJ1300
In Commercial Distribution

  • 00384701300011 ()
  • 00384701300035 ()

  • Width: 25 Millimeter
  • Length: 210 Millimeter
AJ1300

  • Syringe-loaded medication/vaccine injector, manual, professional
No Description
Respironics, Inc.
DreamStation 2 CPAP w/ Humidifier/Cell/B
In Commercial Distribution

  • 00606959063228 ()
DSX410H11C

  • Home CPAP unit
  • Home BPAP unit
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