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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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Cardiovive AT AED Battery - 00812394020317

IntelliSense lithium battery for Cardiovive AT AED with 4 year warranty
Cardiac Science Corporation
9146-303
In Commercial Distribution

  • 00812394020317 ()
9146-303

  • Primary battery

ReActiv8 Stimulation Lead - 05391527772071

Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8145-006
Not in Commercial Distribution

  • 05391527772071 ()
8145

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

PERCLOSE - 08717648013065

PERCLOSE A-T 6F Suture-Medicated Closure System
ABBOTT VASCULAR INC.
12337-04
Not in Commercial Distribution

  • 28717648013069 ()
  • 08717648013065 ()
12337-04

  • Femoral vessel suture implantation set

InCheck™ AT PATIENT ASSISTANT - 00681490872843

ACCESSORY 9465 ACTIVATOR PAT HND HLD 5L
MEDTRONIC, INC.
9465
Not in Commercial Distribution

  • 00681490872843 ()


  • Cardiac pulse generator reader, home-use

InCheck™ AT PATIENT ASSISTANT - 00721902825569

ACTIVATOR 9465AA PATIENT ACTIVATOR US
MEDTRONIC, INC.
9465AA
Not in Commercial Distribution

  • 00721902825569 ()


  • Cardiac pulse generator reader, home-use

ReActiv8 Stimulation Lead - 05391527772262

Stimulation Lead, 65 cm length, Assembled and tray packed at OC, then sterilized and final packaged at OI.
MAINSTAY MEDICAL LIMITED
7M8165-005
In Commercial Distribution

  • 05391527772262 ()
8165

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

ReActiv8 Stimulation Lead - 05391527772279

Stimulation Lead, 65 cm length, Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8165-006
Not in Commercial Distribution

  • 05391527772279 ()
8165

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

ReActiv8 Stimulation Lead - 05391527772064

Stimulation Lead, 45 cm length, Assembled and tray packed at Oscor Caribe, then sterilized and final packaged at Oscor, Inc.
MAINSTAY MEDICAL LIMITED
7M8145-005
In Commercial Distribution

  • 05391527772064 ()
8145

  • Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

IntellaTip MiFi™ Filter Module - 08714729854395

RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M0041212H0
In Commercial Distribution

  • 08714729854395 ()


  • Electronic signal frequency filter

IntellaTip MiFi™ Filter Module - 08714729847939

RF Frequency Filter
BOSTON SCIENTIFIC CORPORATION
M00412120
In Commercial Distribution

  • 08714729847939 ()


  • Electronic signal frequency filter
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