SEARCH RESULTS FOR: ("Japan enterprise-signed app-TG:@crmeb8🆑testflight-signed app.dcf")(774 results)

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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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EndoVue - 00818089021904

ENDOVUE, 19", AMERICAS, JAPAN, BC-SX19-N1418
Nds Surgical Imaging LLC
90K0051
Not in Commercial Distribution

  • 00818089021904 ()


  • Image display unit, colour

Sklar® - 10649111132384

TOHOKU JAPAN TOWEL FCP 5"
SKLAR CORPORATION
47-2975
In Commercial Distribution

  • 10649111132384 ()


  • Towel clamp, reusable

Sklar® - 10649111132179

TOHOKU JAPAN TOWEL FCP 4"
SKLAR CORPORATION
47-2974
In Commercial Distribution

  • 10649111132179 ()


  • Towel clamp, reusable

NuVasive - 00887517913326

Universal Ring Curette Straight - Japan
Nuvasive, Inc.
7175023
In Commercial Distribution

  • 00887517913326 ()


  • Neurosurgical curette, single-use

NuVasive - 00887517913319

Universal Bone Graft Tamp - Japan
Nuvasive, Inc.
7175022
In Commercial Distribution

  • 00887517913319 ()


  • Surgical tamp, reusable

NuVasive - 00887517885562

Universal Nerve Retractor S - Japan
Nuvasive, Inc.
7175017
In Commercial Distribution

  • 00887517885562 ()


  • Surgical retraction system, reusable

TANDEM - 00885556026267

TANDEM TRIAL HANDLE 26MM JAPAN
Smith & Nephew, Inc.
71363037
In Commercial Distribution

  • 00885556026267 ()
71363037

  • Surgical instrument handle, non-torque-limiting

TANDEM - 00885556025970

TANDEM TRIAL HANDLE 22MM JAPAN
Smith & Nephew, Inc.
71363035
In Commercial Distribution

  • 00885556025970 ()
71363035

  • Surgical instrument handle, non-torque-limiting

Model 4000 - 15099169400396

4000 RESPIRATORY MONITOR ASMA-1 JAPAN
VITALOGRAPH (IRELAND) LIMITED
4000
In Commercial Distribution

  • 05099169400399 ()
  • 15099169400396 ()
  • 35099169400390 ()


  • Expiratory peak flow meter, digital

De Soutter Medical - 05051471006379

PS5 POWER SUPPLY - 100V JAPAN
DE SOUTTER MEDICAL LIMITED
609063
Not in Commercial Distribution

  • 05051471006379 ()
609063

  • Cast cutter vacuum system

DeVilbiss - 00885304009634

Disposable Suction Canister for Japan
DEVILBISS HEALTHCARE LLC
7305AP-632
Not in Commercial Distribution

  • 00885304009634 ()
7305AP-632

  • Surgical suction system collection container, single-use

Start-Up Kit Japan - 00849111050081

9 foot tubing set including integral air trap chamber and stainless steel heat exchange coil
Zoll Circulation, Inc.
CG-500D
In Commercial Distribution

  • 00849111050081 ()

  • Length: 9 Feet
8700-0785-03

  • Intravascular core temperature regulation system start kit

Uscan System (Japan) - 09353278000083

General ultrasound imaging system, battery-powered
ECHONOUS, INC.
P004104
In Commercial Distribution

  • 09353278000083 ()


  • Hand-held ultrasound imaging system, body-surface

Medline Industries, Inc. - 10195327615864

JAPAN 25G 1.5 RB HYPO NEEDLE
MEDLINE INDUSTRIES, INC.
SAMPCJ004
In Commercial Distribution

  • 10195327615864 ()
SAMPCJ004

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

Natus - 05713315009051

Aurical Freefit without charger (Japan only)
Natus Medical Denmark ApS
8-62-45300
In Commercial Distribution

  • 05713315009051 ()


  • Hearing aid tester, electrical

PerforMax - 00606959011861

PerforMax Disposable SE SA, Japan, Small
Respironics, Inc.
00
In Commercial Distribution

  • 30606959011862 ()
  • 00606959011861 ()
1055002

  • CPAP/BPAP face mask, single-use

FITLIFE - 00606959023031

FitLife Mask with Headgear, Large, Japan
Respironics, Inc.
FitLife Mask with Headgear, Large, Japan
Not in Commercial Distribution

  • 00606959023031 ()
1060806

  • CPAP/BPAP face mask, reusable

FITLIFE - 00606959023024

FitLife Mask with Headgear, Small, Japan
Respironics, Inc.
FitLife Mask with Headgear, Small, Japan
Not in Commercial Distribution

  • 00606959023024 ()
1060805

  • CPAP/BPAP face mask, reusable

DreamStation - 00606959048973

DreamStation Cellular Modem with Oximetry, Japan
Respironics, Inc.
DreamStation Cellular Modem with Oximetry, JP
Not in Commercial Distribution

  • 00606959048973 ()
100630C

  • Clinical laboratory information system

ComfortGel Blue - 00606959043893

ComfortGel Blue Full Mask, Large, Japan
Respironics, Inc.
ComfortGel Blue Full Mask, Large, Japan
Not in Commercial Distribution

  • 00606959043893 ()
1081842

  • CPAP/BPAP face mask, reusable
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