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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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WATCHMAN® Access System - 08714729838203

Access Sheath with Dilator
BOSTON SCIENTIFIC CORPORATION
M635TU20060
In Commercial Distribution

  • 08714729838203 ()
M635TU20060

  • Cardiac occluder delivery kit

WATCHMAN® Access System - 08714729838197

Access Sheath with Dilator
BOSTON SCIENTIFIC CORPORATION
M635TU10060
In Commercial Distribution

  • 08714729838197 ()
M635TU10060

  • Cardiac occluder delivery kit

OPRA Implant System - 07340152101440

Drill 7mm with Entrance
Integrum AB
1308
In Commercial Distribution

  • 07340152101440 ()


  • Internal-external leg prosthesis osseointegration bar

FLOSEAL HEMOSTATIC MATRIX - 00085412827957

Floseal with Recothrom - 5mL
BAXTER HEALTHCARE CORPORATION
ADS202105
In Commercial Distribution

  • 50085412827952 ()
  • 00085412827957 ()
ADS202105

  • Collagen haemostatic agent, non-antimicrobial

FLOSEAL HEMOSTATIC MATRIX - 00085412827896

Floseal with Recothrom - 10mL.
BAXTER HEALTHCARE CORPORATION
ADS202110
In Commercial Distribution

  • 50085412827891 ()
  • 00085412827896 ()
ADS202110

  • Collagen haemostatic agent, non-antimicrobial

Earhook - 07630016851216

Standard with grip (10)
Advanced Bionics AG
CI-6147-013
Not in Commercial Distribution

  • 07630016851216 ()
  • 07630016855856 ()


  • Cochlear implant/auditory brainstem implant sound processor

Earhook - 07630016851209

Small with grip (10)
Advanced Bionics AG
CI-6147-012
Not in Commercial Distribution

  • 07630016851209 ()
  • 07630016855863 ()


  • Cochlear implant/auditory brainstem implant sound processor

NA - 00884838003361

External Paddles with PCI
Philips Medical Systems Hsg
861269
In Commercial Distribution

  • 00884838003361 ()
M4746A

  • Internal defibrillation electrode, adult, reusable

GYNECARE THERMACHOICE - 10705031050730

With Fluid Ciculation - Thermal Balloon Ablation Silicone Catheter with Fluid Circulation. For use only with GYNECARE THERMACHOICE TM UBT System Controller
Ethicon Inc.
TC003
Not in Commercial Distribution

  • 20705031050737 ()
  • 10705031050730 ()
TC003

  • Circulating-fluid endometrial-ablation catheter

SJM™ - 05415067018854

Nonadhesive Pouch with Belt, EPG
ST. JUDE MEDICAL, INC.
1214
In Commercial Distribution

  • 05415067018854 ()
  • 15415067018851 ()
1214

  • Personal device holder, reusable
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