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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Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-26-090-30U
In Commercial Distribution

  • 00843576154636 ()

  • Outer Diameter: 26 Millimeter
  • Outer Diameter: 30 Millimeter
  • Length: 106 Millimeter
  • Catheter Gauge: 19 French
28-M4-26-090-30U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-090-34U
In Commercial Distribution

  • 00843576154018 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 34 Millimeter
  • Length: 106 Millimeter
  • Catheter Gauge: 20 French
28-M4-24-090-34U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-090-32U
In Commercial Distribution

  • 00843576153929 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 32 Millimeter
  • Length: 106 Millimeter
  • Catheter Gauge: 20 French
28-M4-24-090-32U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-M4-24-090-30U
In Commercial Distribution

  • 00843576153837 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 30 Millimeter
  • Length: 106 Millimeter
  • Catheter Gauge: 19 French
28-M4-24-090-30U

  • Descending thoracic aorta endovascular stent-graft
Microdialysis analyzer using substance specific reagents to evaluate the concentrations in the samples given by the Microdialysis sampling system (Catheter, 106 MD Pump and Microvials).
M DIALYSIS INC.
Clinical
In Commercial Distribution

  • 07332699000744 ()
  • 07332699000607 ()
8003295

  • Microdialysis system analyser
TYPE: MINI, PERMANENT, No.106 RANGE: 121-139gf(1.18-1.36N) MATERIAL: ISO 5832-3/ASTM F136, ISO 5832-2/ASTM F1341G2 BLADE: CURVED(SLIM) MAXIMUM OPENING: 6.5mm GRIP SURFACE: SERRATED
MIZUHO CORPORATION
17-002-21
In Commercial Distribution

  • 04946329138795 ()

  • Length: 5.5 Millimeter
17-002-21

  • Aneurysm clip
106" (269cm) Universal 20 drop spike, back check valve (BCV), 2 needle-free Y-sites 90" and 10" above distal end, slide clamp, roller clamp, male spin luer lock
PATHEN MEDICAL LLC
FK30106G
In Commercial Distribution

  • 10850005864209 ()
  • 00850005864202 ()


  • Intravenous administration tubing extension set
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
106 19 U-BK 51
In Commercial Distribution

  • 04582647306104 ()


  • Spectacle frame
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
106 19 A-BK 51
In Commercial Distribution

  • 04582647306081 ()


  • Spectacle frame
106"(269cm)Bifuse Trans Set w/2 Ck Vlvs,2 3-Way Stpk,3 MicroClave® (TPN Ring) 0.2 Fltr, Smbore Trifuse Set, 2 Ext, Drop-In Set w/MicroClave®
ICU MEDICAL, INC.
Z3316
In Commercial Distribution

  • 10887709031118 ()
  • 00887709031111 ()


  • Basic intravenous administration set, noninvasive
EM Stylet
Stryker Leibinger GmbH & Co. KG
8900-200-200
In Commercial Distribution

  • 37613327499712 ()
  • 07613327499711 ()
8900-200-200

  • Intracranial catheter navigation transmitter stylet
No Description
Lazurite Holdings LLC
AF0015-101-10
In Commercial Distribution

  • 10860001744221 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0030-101-10
In Commercial Distribution

  • 00860001744293 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0029-101-10
In Commercial Distribution

  • 00860001744286 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0028-101-10
In Commercial Distribution

  • 00860001744279 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0014-101-10
In Commercial Distribution

  • 00860001744262 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0013-101-11
In Commercial Distribution

  • 00860001744255 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0002-101-10
In Commercial Distribution

  • 00860001744248 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0004-101-10
In Commercial Distribution

  • 00860001744231 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0003-101-10
In Commercial Distribution

  • 00860001744224 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0005-101-10
In Commercial Distribution

  • 00860001744217 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0001-101-10
In Commercial Distribution

  • 00860001744200 ()


  • Video camera surgical microscope system
No Description
Lazurite Holdings LLC
AF0030-101-10
In Commercial Distribution

  • 00850045863005 ()


  • Video camera surgical microscope system
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
106 23 U-BR TORTOISE 51
In Commercial Distribution

  • 04582647306111 ()


  • Spectacle frame
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
106 23 A-BR TORTOISE 51
In Commercial Distribution

  • 04582647306098 ()


  • Spectacle frame
CABLE FMET-IM-RSC
MEDTRONIC, INC.
FMET-IM-RSC
In Commercial Distribution

  • 00860001276138 ()


  • Laser speckle blood flowmeter
SYSTEM FMET-IM-SYS
MEDTRONIC, INC.
FMET-IM-SYS
In Commercial Distribution

  • 00860001276121 ()


  • Laser speckle blood flowmeter
SYSTEM SERVICED FMET-IM-SYS-S
MEDTRONIC, INC.
FMET-IM-SYS-S
In Commercial Distribution

  • 00763000502843 ()


  • Laser speckle blood flowmeter
OCS Battery
TRANSMEDICS, INC.
1408
In Commercial Distribution

  • B00912501 ()
  • B00912500 ()

  • Height: 3 Inch
  • Width: 2 Inch
  • Length: 10 Inch
1408

  • Portable/mobile rechargeable battery pack
Lateral TTC Fusion Plate, Ankle, Sterile Packed
OSTEOMED LLC
336-9002-SP
In Commercial Distribution

  • 00842528128978 ()

  • Length: 4 Inch
336-9002-SP

  • Orthopaedic fixation plate, non-bioabsorbable
Lateral TT Fusion Plate, Ankle, Sterile Packed
OSTEOMED LLC
336-9001-SP
In Commercial Distribution

  • 00842528128954 ()

  • Length: 2.8 Inch
336-9001-SP

  • Orthopaedic fixation plate, non-bioabsorbable
Battery pack (for CU-171R, CU-172R)
NIHON KOHDEN CORPORATION
SB-970P
In Commercial Distribution

  • 04931921023631 ()
SB-970P

  • Portable/mobile rechargeable battery pack
Battery pack (for CU-151R, CU-152R)
NIHON KOHDEN CORPORATION
SB-950P
In Commercial Distribution

  • 04931921023624 ()
SB-950P

  • Portable/mobile rechargeable battery pack
Adapter, 450-0390 OsteoPower Footswitch to ECOS Power Console
OSTEOMED LLC
470-0392
In Commercial Distribution

  • 00845694091107 ()

  • Weight: 44.8 Gram
470-0392

  • General internal orthopaedic fixation system implantation kit
Adapter, 470-0390 ECOS Footswitch to OsteoPower Console
OSTEOMED LLC
470-0391
In Commercial Distribution

  • 00845694091091 ()

  • Weight: 45.2 Gram
470-0391

  • General internal orthopaedic fixation system implantation kit
Footswitch, ECOS
OSTEOMED LLC
470-0390
In Commercial Distribution

  • 00845694091077 ()

  • Weight: 2.18 Kilogram
470-0390

  • General internal orthopaedic fixation system implantation kit
Irrigation Module, ECOS
OSTEOMED LLC
470-0012
In Commercial Distribution

  • 00845694091060 ()

  • Weight: 1.7 Kilogram
470-0012

  • General internal orthopaedic fixation system implantation kit
Power Control Console, ECOS
OSTEOMED LLC
470-0005
In Commercial Distribution

  • 00845694091053 ()

  • Weight: 6.62 Kilogram
470-0005

  • General internal orthopaedic fixation system implantation kit
Replacement Battery, Sterile, 2-Pack
OSTEOMED LLC
110-1000-SP-02
In Commercial Distribution

  • 00845694098038 ()
110-1000-SP-02

  • General internal orthopaedic fixation system implantation kit
Replacement Battery, Sterile
OSTEOMED LLC
110-1000-SP
In Commercial Distribution

  • 00845694098021 ()
110-1000-SP

  • General internal orthopaedic fixation system implantation kit
No Description
TAKAGI SEIKO CO.,LTD.
MARCO ULTRA M4
Not in Commercial Distribution

  • 06909071678467 ()


  • Ophthalmic examination slit lamp
Tonsil Sponge - RF and X-ray Detectable Tape Strung - Cotton Filled
Covidien LP
TST-1500C-1
In Commercial Distribution

  • 20884521701165 ()
  • 10884521701168 ()
  • 30884521701162 ()

  • Outer Diameter: 1.5 Inch


  • Radiopaque woven surgical sponge
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
MP-714SF FRAME 106 VIOLET DECO F
In Commercial Distribution

  • 04582644477265 ()


  • Spectacle frame
No Description
MASUNAGA OPTICAL MFG.CO.,LTD.
MP-714S P.SET 106 VIOLET DECO F
In Commercial Distribution

  • 04582644477128 ()


  • Spectacle frame
Cardiac Resynchronization Therapy Pacemaker
BOSTON SCIENTIFIC CORPORATION
V273
In Commercial Distribution

  • 00802526536670 ()


  • Cardiac resynchronization therapy implantable pacemaker
Cardiac Resynchronization Therapy Pacemaker
BOSTON SCIENTIFIC CORPORATION
V272
In Commercial Distribution

  • 00802526536663 ()


  • Cardiac resynchronization therapy implantable pacemaker
Cardiac Resynchronization Therapy Pacemaker
BOSTON SCIENTIFIC CORPORATION
V173
In Commercial Distribution

  • 00802526536632 ()


  • Pacing lead extraction kit, reusable
Cardiac Resynchronization Therapy Pacemaker
BOSTON SCIENTIFIC CORPORATION
V172
In Commercial Distribution

  • 00802526536625 ()


  • Cardiac pulse generator test magnet
Probe
FUJIFILM CORPORATION
C41V
In Commercial Distribution



  • Rectal/vaginal ultrasound imaging transducer
No Description
GE HEALTHCARE JAPAN CORPORATION
C721
In Commercial Distribution

  • 00840682117371 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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