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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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GRU Tibia - 09340499005409

GRU Tibia Size 5 7.5mm
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GRU-5T-7.5-P-R
Not in Commercial Distribution

  • 09340499005409 ()

  • Size 5
GRU-5T-7.5-P-R

  • Uncoated unicondylar knee tibia prosthesis, polyethylene

GRU Tibia - 09340499005393

GRU Tibia Size 5 6.5mm
GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED
GRU-5T-6.5-P-R
Not in Commercial Distribution

  • 09340499005393 ()

  • Size 5
GRU-5T-6.5-P-R

  • Uncoated unicondylar knee tibia prosthesis, polyethylene

Futura™ FDI - 00846832006526

No Description
TORNIER, INC.
FDI-05
Not in Commercial Distribution

  • 00846832006526 ()

  • Size 5


  • Total metatarsophalangeal joint prosthesis, one-piece

ACE Surgical Supply - 00614950008865

ACE 0.5 GRAM CALCIUM SULFATE HEMIHYDRATE KIT
ACE SURGICAL SUPPLY CO., INC.
5052002
In Commercial Distribution

  • 00614950008865 ()

  • .5 G
5052002

  • Dental root surface conditioner

REGENX PuraCAL - 00614950008681

PuraCAL .5g Kit Medical Grade Calcium Sulfate
ACE SURGICAL SUPPLY CO., INC.
PGCS05
In Commercial Distribution

  • 00614950008681 ()

  • .5 G
PGCS05

  • Dental root surface conditioner

REGENX PuraXEN - 00614950008582

PuraXEN Cancellous .5cc .25-1mm Particulate
ACE SURGICAL SUPPLY CO., INC.
PGAB05
In Commercial Distribution

  • 00614950008582 ()

  • .5 cc
PGAB05

  • Dental bone matrix implant, animal-derived

U2™ Knee - 04719872162971

Tibial baseplate trial, PSA, #5
UNITED ORTHOPEDIC CORP.
2203-6050
In Commercial Distribution

  • 04719872162971 ()

  • PSA, #5
2203-6050

  • Knee tibia prosthesis trial, reusable

U2™ Knee - 04719872154792

Tibial trial set, UC, #5
UNITED ORTHOPEDIC CORP.
2304-2450
In Commercial Distribution

  • 04719872154792 ()

  • UC, #5
2304-2450

  • Knee tibia prosthesis trial, reusable

U2™ Knee - 04719872169659

Femoral posterior augment trial, #5, 8mm
UNITED ORTHOPEDIC CORP.
2603-6052
In Commercial Distribution

  • 04719872169659 ()

  • #5, 8mm
2603-6052

  • Knee femur prosthesis trial, reusable

U2™ Knee - 04719872169642

Femoral posterior augment trial, #5, 4mm
UNITED ORTHOPEDIC CORP.
2603-6051
In Commercial Distribution

  • 04719872169642 ()

  • #5, 4mm
2603-6051

  • Knee femur prosthesis trial, reusable
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