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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(577) CONSOLE PA-03, PB-2, SYNTHESIS III, JAPAN (PACKED) RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 577
In Commercial Distribution

  • 00855005006164 ()
SA-06410

  • Ophthalmic solid-state laser system, photodisruption
(532) CONSOLE PA-03, PB-2, SYNTHESIS III, JAPAN (PACKED) RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 532
In Commercial Distribution

  • 00855005006157 ()
SA-06409

  • Ophthalmic solid-state laser system, photodisruption
SET,PKG,150ML FASTURN,RAD,JAPAN,MC,JA2 (85232878)
BAYER MEDICAL CARE INC.
150-FT
In Commercial Distribution

  • 40616258009931 ()
  • 00616258009933 ()
150-FT

  • Angiographic syringe
De Mayo Knee Positioner® - Aluminum Boot - JAPAN ONLY
Innovative Medical Products, Inc
803-AB
In Commercial Distribution

  • 00696588003702 ()
803-AB

  • Leg procedure positioner
CURETTE, DOUBLE END, GRACEY #11-12 LONG SHANK/JAPAN BLADE
NORDENT MANUFACTURING INC
CESCGR11-12LJ
In Commercial Distribution

  • 00840018618053 ()


  • Periodontal curette
CURETTE, GRACEY #13-14 RIGID, JAPAN BLADE, DURALITE ROUND HANDLE
NORDENT MANUFACTURING INC
RESCG13R-14RJ
In Commercial Distribution

  • 00840018614901 ()


  • Periodontal curette
Fixed, Axial Large Custom Tri-Lobe Custom Mesystem Japan, Grey
TECOMET INC.
NR134001-E
In Commercial Distribution

  • 00841435101838 ()


  • Surgical instrument handle, non-torque-limiting
PerforMax with Entrainment Elbow, Single Patient Use, Japan, Small
Respironics, Inc.
PerforMax Mask with EE, Single Patient Use, Small, JP
In Commercial Distribution

  • 30606959011848 ()
  • 00606959011847 ()
1055000

  • CPAP/BPAP face mask, single-use
AMARA MASK WITH RS FRAME AND HEADGEAR, LARGE, JAPAN
Respironics, Inc.
AMARA MASK with RS FRAME and RS Headgear, Large, Japan
Not in Commercial Distribution

  • 00606959025097 ()
1090246

  • CPAP/BPAP face mask, reusable
AMARA MASK WITH RS FRAME AND HEADGEAR, MEDIUM, JAPAN
Respironics, Inc.
AMARA MASK with RS FRAME AND Headgear, Medium, Japan
Not in Commercial Distribution

  • 00606959025080 ()
1090245

  • CPAP/BPAP face mask, reusable
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