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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 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

ConstaVac CBC II - 00855168008234

ConstaVac CBCII with Quick Disconnect (No Drain)
3T MEDICAL SYSTEMS, INC.
225-028-085
In Commercial Distribution

  • 00855168008241 ()
  • 00855168008234 ()
225-028-085

  • Whole-blood-recovery autotransfusion system, powered

extriCARE - 00879766005655

NPWT Bandage-Extra large oval with tubing set
OAKWELL DISTRIBUTION, INC.
EC2400-IM
In Commercial Distribution

  • 20879766005659 ()
  • 00879766005655 ()


  • Multi-purpose low-vacuum suction system

Sterimed - 00850341007295

C-Arm Cover with Straps 44" X 80"
STERIMED LLC
4480S
In Commercial Distribution

  • 20850341007299 ()
  • 10850341007292 ()
  • 00850341007295 ()


  • C-arm drape

Jewel Precision - 00850043393092

JP-24-FLA Filter Retainer with gasket, replacement part
Jewel Precision Sheet Metal & Machining Inc
100-0004
In Commercial Distribution

  • 00850043393092 ()
100-0004

  • Instrument transport trolley system

Hemaseal & Cide - 00859787002000

10mL bottle - dental desensitizer with 4% chlorhexadine
ADVANTAGE DENTAL PRODUCTS INC
170
In Commercial Distribution

  • 10859787002007 ()
  • 00859787002000 ()

  • Total Volume: 10 Milliliter


  • Dental coating, tooth-desensitizing

Negative Control Serum - 10888234400622

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403887
Not in Commercial Distribution

  • 10888234400622 ()
403887

  • HLA class II antigen tissue typing IVD, kit, multiplex

Positive Control Serum - 10888234400615

For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403892
Not in Commercial Distribution

  • 10888234400615 ()
403892

  • HLA class II antigen tissue typing IVD, kit, multiplex

Negative Control Serum - 10888234400592

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628209
Not in Commercial Distribution

  • 10888234400592 ()
628209

  • HLA class I antigen tissue typing IVD, kit, multiplex

Positive Control Serum - 10888234400585

For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628208
Not in Commercial Distribution

  • 10888234400585 ()
628208

  • HLA class I antigen tissue typing IVD, kit, multiplex
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