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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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Paxeon Origin Coxa Vara Hip Stem - 08177570200450

Origin Stem, Coxa Vara Size 11
PAXEON RECONSTRUCTION LLC
PR111-18-1104
In Commercial Distribution

  • 08177570200450 ()


  • Coated hip femur prosthesis, modular

Paxeon Origin Coxa Vara Hip Stem - 08177570200412

Origin Stem, Coxa Vara Size 10
PAXEON RECONSTRUCTION LLC
PR111-18-1004
In Commercial Distribution

  • 08177570200412 ()


  • Coated hip femur prosthesis, modular

Paxeon Origin Coxa Vara Hip Stem - 08177570200375

Origin Stem, Coxa Vara Size 9
PAXEON RECONSTRUCTION LLC
PR111-18-0904
In Commercial Distribution

  • 08177570200375 ()


  • Coated hip femur prosthesis, modular

Orthopaedic & Spine Development (OSD) - 03760178394857

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002-02
In Commercial Distribution

  • 03760178394857 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394840

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002
In Commercial Distribution

  • 03760178394840 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394833

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0001
In Commercial Distribution

  • 03760178394833 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394826

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-SQA-0025
In Commercial Distribution

  • 03760178394826 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394802

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit

Gamma Lewis Blood Group Substance - 10888234000853

Gamma Lewis Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-Lea and anti-Leb activity in serum or plasma. Gamma Lewis Blood Group Substance is a standardized solution of human Lea and Leb blood group substances in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007702
In Commercial Distribution

  • 10888234000853 ()
0007702

  • Immunoglobulin removal reagent IVD

Gamma P1 Blood Group Substance - 10888234000846

Gamma P1 Blood Group Substance is intended for use in assistance in the identification of unexpected blood group antibodies by neutralizing anti-P1 activity in serum or plasma. Gamma P1 Blood Group Substance is a standardized solution of avian P1 blood group substance in phosphate-buffered saline. This package configuration is one (1) vial of 2 mL volume.
IMMUCOR, INC.
0007700
In Commercial Distribution

  • 10888234000846 ()
0007700

  • Immunoglobulin removal reagent IVD

Origin NS Stem - 09348215087289

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5052
In Commercial Distribution

  • 09348215087289 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087272

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5051
In Commercial Distribution

  • 09348215087272 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087265

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5042
In Commercial Distribution

  • 09348215087265 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087258

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5041
In Commercial Distribution

  • 09348215087258 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087241

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5032
In Commercial Distribution

  • 09348215087241 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087234

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5031
In Commercial Distribution

  • 09348215087234 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087227

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5022
In Commercial Distribution

  • 09348215087227 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087210

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5021
In Commercial Distribution

  • 09348215087210 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087203

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5012
In Commercial Distribution

  • 09348215087203 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087197

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5011
In Commercial Distribution

  • 09348215087197 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087180

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5002
In Commercial Distribution

  • 09348215087180 ()


  • Coated hip femur prosthesis, modular

Origin NS Stem - 09348215087173

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-5001
In Commercial Distribution

  • 09348215087173 ()


  • Coated hip femur prosthesis, modular

Origin Instrument Tray - 09348215039882

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-001
In Commercial Distribution

  • 09348215039882 ()


  • Instrument tray, reusable

Origin Trial Neck - 09348215039813

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-022
In Commercial Distribution

  • 09348215039813 ()


  • Surgical implant template, reusable

Origin Trial Neck - 09348215039806

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-021
In Commercial Distribution

  • 09348215039806 ()


  • Surgical implant template, reusable

Origin Trial Neck - 09348215039790

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-020
In Commercial Distribution

  • 09348215039790 ()


  • Surgical implant template, reusable

Origin Hip Stem - 09348215051822

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1803
In Commercial Distribution

  • 09348215051822 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051815

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1603
In Commercial Distribution

  • 09348215051815 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051808

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1503
In Commercial Distribution

  • 09348215051808 ()


  • Coated femoral stem prosthesis, modular

Origin Hip Stem - 09348215051792

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
D111-18-1403
In Commercial Distribution

  • 09348215051792 ()


  • Coated femoral stem prosthesis, modular
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