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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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SR PIP - 00886385019857

SIZE 2: PIP PROXIMAL BROACH ASSEMBLY (GREEN)
Stryker GmbH
17-1326
In Commercial Distribution

  • 00886385019857 ()


  • Orthopaedic broach

SR PIP - 00886385019840

SIZE 1: PIP PROXIMAL BROACH ASSEMBLY (YELLOW)
Stryker GmbH
17-1325
In Commercial Distribution

  • 00886385019840 ()


  • Orthopaedic broach

Lumipulse G Mesothelin Calibrator - 04987270233436

No Description
FUJIREBIO INC.
233436
In Commercial Distribution

  • 04987270233436 ()

  • Size Type = Units per kit; Units = 3; Unit of Measure = 4.5mLs


  • Soluble mesothelin-related peptide (SMRP) IVD, calibrator

MESOMARK - 00869164000000

No Description
Fujirebio Diagnostics, Inc.
801-905
Not in Commercial Distribution

  • 00869164000000 ()

  • Size Type = Tests Per Kit; Size Unit = 96; Unit of Measure = Tests


  • Mucin-like carcinoma-associated antigen (MCA) IVD, kit, enzyme immunoassay (EIA)

NeVa VS - Vessel Dilation Device - 00851279008767

Temporary percutaneous transluminal cerebral artery dilation device.
Vesalio
VS-4022-F1RR
In Commercial Distribution

  • 00851279008767 ()
VS-4022-F1RR

  • Thrombectomy suction catheter

Argus II Retinal Prosthesis Retinal Tacks - 10856264005322

The Argus II Retinal Tack is used to affix the electrode array of the Retinal Prosthesis to the retina.
Second Sight Medical Products, Inc.
011006-001
Not in Commercial Distribution

  • 10856264005322 ()
  • 00856264005325 ()
011006

  • Retinal tack

Lumipulse G Mesothelin Immunoreaction Cartridges - 04987270235157

No Description
FUJIREBIO INC.
235157
In Commercial Distribution

  • 04987270235157 ()

  • Size Type = Tests Per kit; Size Unit = 42; Unit of Measure = Tests


  • Soluble mesothelin-related peptide (SMRP) IVD, kit, chemiluminescent immunoassay

SR MCP - 00886385020952

S.R. MCP AWL ASSEMBLY, SIZE .062
Stryker GmbH
17-1535
In Commercial Distribution

  • 00886385020952 ()


  • Bone awl, reusable

SR PIP - 00886385020044

SIZE .062: PIP AWL ASSEMBLY
Stryker GmbH
17-1345
In Commercial Distribution

  • 00886385020044 ()


  • Bone awl, reusable

NA - 04048551094754

Obturator for 26161 U
Karl Storz GmbH & Co. KG
26161UO
In Commercial Distribution

  • 04048551094754 ()


  • Rigid endoscope obturator
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