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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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R&D Batteries, Inc. - 00810149097324

Baxter 35223 Exchange
R & D Batteries, Inc.
6596
Not in Commercial Distribution

  • 00810149097324 ()


  • Portable/mobile rechargeable battery pack

Leksell Gamma Knife Perfexion/Icon - 07340048306591

CC EXCHANGE TOOL
Elekta Instrument AB
1002491
In Commercial Distribution

  • 07340048306591 ()


  • Teletherapy radionuclide system, conventional

Hemolung® CR4 Controller - 00850046004056

Hemolung® CR4 Controller
Alung Technologies, Inc.
21000
Not in Commercial Distribution

  • 00850046004056 ()


  • Mobile extracorporeal gas exchange system

Centurion - 00653160002003

C.A.P.D. TUBING EXCHANGE TRAY
CENTURION MEDICAL PRODUCTS CORPORATION
HT80
In Commercial Distribution

  • 50653160002008 ()
  • 00653160002003 ()
HT80

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

Sterling Medical Products - 00685404001770

NEONATAL EXCHANGE TRANSFUSION TRAY
APOLLO MEDICAL PRODUCTS CORP.
ETT-NW
In Commercial Distribution

  • 10685404001777 ()
  • 00685404001770 ()


  • General surgical procedure kit, medicated

Simpact Tri-Fin - 00190837062644

Exchange Pin, Stainless Steel
Life Spine, Inc.
152-103
In Commercial Distribution

  • 00190837062644 ()
152-103

  • Spinal intraoperative positioning pin, single-use

TORQ TNT Exchange Tube - 00810055523719

TORQ TNT Exchange Tube
Si-Bone Inc.
501775
In Commercial Distribution

  • 00810055523719 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit

STAINLESS STEEL FEMORAL NAILING SYSTEM - 18032568034172

GUIDE WIRE EXCHANGE TUBE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568034172 ()
17353

  • General internal orthopaedic fixation system implantation kit

CENTRONAIL TITANIUM HUMERAL NAILING SYSTEM - 18032568039740

HUMERAL WIRE EXCHANGE TUBE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18032568039740 ()
178353

  • General internal orthopaedic fixation system implantation kit

WA Holter System - 90815187020283

HR300 Holter Repair Exchange
GLOBAL INSTRUMENTATION, LLC
HR300
In Commercial Distribution

  • 90815187020283 ()
402811

  • Electrocardiographic ambulatory recorder
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