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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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Fifty50 Sport - 00892896000260

Fifty50 Sport Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163424-201
In Commercial Distribution

  • 00892896000260 ()
  • 10892896000267 ()


  • Home-use/point-of-care blood glucose monitoring system IVD

Endovenous Radiofrequency Ablation (RFA) Catheter - 08600360005107

Endovenous Radiofrequency Ablation (RFA) Catheter 7-60
Vein360 LLC
VEN-7-60
Not in Commercial Distribution

  • 08600360005107 ()
VEN-7-60

  • Radio-frequency ablation system

Endovenous Radiofrequency Ablation (RFA) Catheter - 08600360005022

Endovenous Radiofrequency Ablation (RFA) Catheter 3-60
Vein360 LLC
VEN-3-60
Not in Commercial Distribution

  • 08600360005022 ()
VEN-3-60

  • Radio-frequency ablation system

Endovenous Radiofrequency Ablation (RFA) Catheter - 08600360005008

Endovenous Radiofrequency Ablation (RFA) Catheter 7-100
Vein360 LLC
VEN-7-100
Not in Commercial Distribution

  • 08600360005008 ()
VEN-7-100

  • Radio-frequency ablation system

Fifty50 - 00892896000086

Fifty50 Blood Glucose Monitoring System 2.0
i-SENS, Inc.
163308-302
In Commercial Distribution

  • 10892896000083 ()
  • 00892896000086 ()


  • Home-use/point-of-care blood glucose monitoring system IVD

PASCAL Synthesis - 00855005006034

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

  • 00855005006034 ()
SA-06285

  • Ophthalmic solid-state laser system, photodisruption

PASCAL Synthesis - 00855005006027

(532) CONSOLE PA-03, SYNTHESIS III PACKED B RELEASE
TOPCON MEDICAL LASER SYSTEMS, INC.
PASCAL Synthesis 532
In Commercial Distribution

  • 00855005006027 ()
SA-06284

  • Ophthalmic solid-state laser system, photodisruption

OPER CHOLANGIOGRAPHY CATHETER - 00858690006310

OPER CHOLANGIOGRAPHY CATHETER ORC TYPE B PN 68010-01M
RANFAC CORP.
18 GAUGE X 7"
In Commercial Distribution

  • 20858690006314 ()
  • 10858690006317 ()
  • 00858690006310 ()

  • 18 GAUGE x 7"
ORC-B

  • Rigid endoscopic cannula, single-use

Rexious - 08809319786276

Poly Screw B type (Double) 8.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319786276 ()

  • Length: 90 Millimeter
  • Diameter 8.5mm
FX.PD.8590

  • Bone-screw internal spinal fixation system, non-sterile

Rexious - 08809319786269

Poly Screw B type (Double) 8.5 x 85mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319786269 ()

  • Diameter 8.5mm
  • Length: 85 Millimeter
FX.PD.8585

  • Bone-screw internal spinal fixation system, non-sterile
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