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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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Anti-Human IgG/A/M Conjugate - 10888234500575

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404588
Not in Commercial Distribution

  • 10888234500575 ()
404588

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Positive Platelet Control (Positive Eluate Control) - 10888234500568

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404579
Not in Commercial Distribution

  • 10888234500568 ()
404579

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Normal Platelet Control (Negative Eluate Control) - 10888234500551

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404578
Not in Commercial Distribution

  • 10888234500551 ()
404578

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500544

For Use with PakPlus
IMMUCOR GTI DIAGNOSTICS, INC.
404577
Not in Commercial Distribution

  • 10888234500544 ()
404577

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Negative Serum Control - 10888234500537

For Use with PakAuto
IMMUCOR GTI DIAGNOSTICS, INC.
404576
Not in Commercial Distribution

  • 10888234500537 ()
404576

  • Human platelet antigen (HPA) multiple antibody screening/identification IVD, reagent

Zavation - 00842166178182

Cervical Awl with Stop
Zavation LLC
30-1010
In Commercial Distribution

  • 00842166178182 ()


  • Spinal fixation plate, non-bioabsorbable

Zavation - 00842166176188

Rod Reducer with Handle
Zavation LLC
10-1039
In Commercial Distribution

  • 00842166176188 ()


  • Internal spinal fixation procedure kit, reusable

NA - 04546540365989

PLATE, CURVED, WITH BAR
Stryker Leibinger GmbH & Co. KG
55-06754
In Commercial Distribution

  • 04546540365989 ()

  • Number of Screw Holes: 4.0 Holes
  • Bar Length: 2.4 Millimeter
55-06754

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 04546540365941

PLATE, STRAIGHT, WITH BAR
Stryker Leibinger GmbH & Co. KG
55-06704
In Commercial Distribution

  • 04546540365941 ()

  • Bar Length: 2.4 Millimeter
  • Number of Screw Holes: 4.0 Holes
55-06704

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 04546540365606

Y-PLATE, WITH 8MM BAR
Stryker Leibinger GmbH & Co. KG
55-05152
In Commercial Distribution

  • 04546540365606 ()

  • Bar Length: 8.0 Millimeter
  • Number of Screw Holes: 5.0 Holes
55-05152

  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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