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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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ACE Axcel® - 00857969006709

ACE Axcel Clinical Chemistry System with ISE
ALFA WASSERMANN, INC.
404200-1
In Commercial Distribution

  • 00857969006709 ()
404200-1

  • Multichannel clinical chemistry analyser IVD, point-of-care, line-powered

ACE Alera® - 00857969006693

ACE Alera Clinical Chemistry System with ISE
ALFA WASSERMANN, INC.
402900-1
In Commercial Distribution

  • 00857969006693 ()
402900-1

  • Multichannel clinical chemistry analyser IVD, point-of-care, line-powered

Padlock Clip-12 - 00864345000015

Endoscopic Ligation Clip
APONOS MEDICAL CORPORATION
C913131
Not in Commercial Distribution

  • 00864345000015 ()
C913131

  • Wound clip, non-biodegradable

Padlock Clip-12 - 00864345000008

Endoscopic Ligation Clip
APONOS MEDICAL CORPORATION
C910001
Not in Commercial Distribution

  • 00864345000008 ()
C910001

  • Wound clip, non-biodegradable

Acidified Concentrate Distribution and Storage (ACDS) System - 00852456007092

Acidified Concentrate Distribution and Storage System (ACDS System)
Isopure, Corp.
MD704262
In Commercial Distribution

  • 00852456007092 ()


  • Haemodialysis system fluid mixer

SelectaLyte - 00850229007287

No Description
AWARENESS TECHNOLOGY, INCORPORATED
3910
In Commercial Distribution

  • 00850229007287 ()


  • Ion-selective analyser IVD, semi-automated

HemosIL Rinse Solution (ACLFutura Advance) - 08426950553502

HemosIL Rinse Solution 2L (ACLFutura Advance)
INSTRUMENTATION LABORATORY COMPANY
00020302500
Not in Commercial Distribution

  • 08426950553502 ()
00020302500

  • Buffered sample diluent IVD, manual

HemosIL Rinse Solution (ACL TOP Family) - 08426950075882

HemosIL Rinse Solution (ACL TOP Family) 4000 mL
INSTRUMENTATION LABORATORY COMPANY
00020009700
Not in Commercial Distribution

  • 08426950075882 ()
00020009700

  • Buffered sample diluent IVD, manual

HemosIL Rinse Solution (ACL Futura Advance) - 08426950003083

HemosIL Rinse Solution (ACL Futura Advance) 2 LIT
INSTRUMENTATION LABORATORY COMPANY
00020009320
Not in Commercial Distribution

  • 08426950003083 ()
00020009320

  • Buffered sample diluent IVD, manual

Infinion™ 16 - 08714729837145

70cm 16 Contact Trial Lead Kit
BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
SC-2316-70E
In Commercial Distribution

  • 08714729837145 ()

  • 70 cm Length


  • Analgesic spinal cord electrical stimulation system
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