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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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VITROS - 10758750002788

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802452
In Commercial Distribution

  • 10758750002788 ()
6802452

  • Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750002771

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802451
In Commercial Distribution

  • 10758750002771 ()
6802451

  • Hepatitis B virus core total antibody IVD, kit, chemiluminescent immunoassay

VITROS - 10758750002764

VITROS Immunodiagnostic Products HBsAg Reagent Pack
ORTHO CLINICAL DIAGNOSTICS
6802450
In Commercial Distribution

  • 10758750002764 ()
6802450

  • Hepatitis B virus surface antigen IVD, kit, chemiluminescent immunoassay

Progel - 00801741010026

Progel, Pleural Air Leak Sealant, 4 ml Kit
NEOMEND, INC.
PGPS002
In Commercial Distribution

  • 10801741010023 ()
  • 00801741010026 ()

  • Total Volume: 4 Milliliter
PGPS002

  • Surgical internal adhesive/sealant, human-derived

STEEN Solution™ - 07350069520036

STEEN Solution™ is intended for assessment of isolated lungs after removal from the donor body for eventual transplantation into a recipient.
Xvivo Perfusion AB
19004
In Commercial Distribution

  • 07350069520036 ()

  • Total Volume: 500 Milliliter
19004

  • Donor-organ/tissue/cell preservation solution

Vitagel - 00808232001280

RT3 Surgical Hemostat
Stryker Corporation
2113-0205
Not in Commercial Distribution

  • 00808232001280 ()

  • Total Volume: 4.5 Milliliter
2113-0205

  • Collagen haemostatic agent, non-antimicrobial

Vitagel - 00808232001273

RT3 Surgical Hemostat
Stryker Corporation
2113-0202
Not in Commercial Distribution

  • 00808232001273 ()

  • Total Volume: 2.0 Milliliter
2113-0202

  • Collagen haemostatic agent, non-antimicrobial

Synvisc-One® - 20358468019114

Acid, Hyaluronic, Intraarticular
GENZYME CORPORATION
002401
In Commercial Distribution

  • 20358468019114 ()

  • Total Volume: 6 Milliliter
  • one 6 mL syringe


  • Synovial fluid supplementation medium

Guardian ™ Sensor (3) - 20643169704057

SENSOR MMT-7020A ENLITE3 5PK 2L US
MEDTRONIC MINIMED, INC.
MMT-7020A
In Commercial Distribution

  • 20643169704057 ()
  • 00643169704053 ()


  • Percutaneous interstitial-fluid glucose monitoring system sensor

Elecsys free PSA - 07613336166673

No Description
Roche Diagnostics GmbH
08828601160
In Commercial Distribution

  • 07613336166673 ()
08828601160

  • Free (unbound) prostate specific antigen (fPSA) IVD, control
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