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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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Femoral Stem Extractor Hoop - 00819251021081

Femoral Stem Extractor Hoop
TOTAL JOINT ORTHOPEDICS, INC.
1303.00.000
In Commercial Distribution

  • 00819251021081 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Canal Finder Reamer - 00819251021050

Canal Finder Reamer
TOTAL JOINT ORTHOPEDICS, INC.
1300.00.000
In Commercial Distribution

  • 00819251021050 ()


  • Medullary canal orthopaedic reamer, rigid

Acetabular X-Ray Templates - 00819251021029

Acetabular X-Ray Templates
TOTAL JOINT ORTHOPEDICS, INC.
1212.00.000
In Commercial Distribution

  • 00819251021029 ()


  • Surgical implant template, reusable

Acetabular U-Joint Screwdriver - 00819251021005

Acetabular U-Joint Screwdriver
TOTAL JOINT ORTHOPEDICS, INC.
1210.00.000
In Commercial Distribution

  • 00819251021005 ()


  • Surgical screwdriver, reusable

Acetabular Reamer Driver, Offset - 00819251020992

Acetabular Reamer Driver, Offset
TOTAL JOINT ORTHOPEDICS, INC.
1209.00.000
In Commercial Distribution

  • 00819251020992 ()


  • Acetabular orthopaedic reamer
  • Surgical instrument handle, non-torque-limiting

Acetabular Reamer Driver, Straight - 00819251020985

Acetabular Reamer Driver, Straight
TOTAL JOINT ORTHOPEDICS, INC.
1208.00.000
In Commercial Distribution

  • 00819251020985 ()


  • Acetabular orthopaedic reamer
  • Surgical instrument handle, non-torque-limiting

Anterior Starter Broach - 00819251020497

Anterior Starter Broach
TOTAL JOINT ORTHOPEDICS, INC.
1115.00.000
In Commercial Distribution

  • 00819251020497 ()


  • Orthopaedic broach

Klassic Blade Femoral Broach - 00819251020411

Blade Femoral Broach, size 9
TOTAL JOINT ORTHOPEDICS, INC.
1109.09.000
In Commercial Distribution

  • 00819251020411 ()

  • size 9


  • Orthopaedic broach

Klassic Blade Femoral Broach - 00819251020404

Blade Femoral Broach, size 8
TOTAL JOINT ORTHOPEDICS, INC.
1109.08.000
In Commercial Distribution

  • 00819251020404 ()

  • size 8


  • Orthopaedic broach

Klassic Blade Femoral Broach - 00819251020398

Blade Femoral Broach, size 7
TOTAL JOINT ORTHOPEDICS, INC.
1109.07.000
In Commercial Distribution

  • 00819251020398 ()

  • size 7


  • Orthopaedic broach

Klassic Blade Femoral Broach - 00819251020381

Blade Femoral Broach, size 6
TOTAL JOINT ORTHOPEDICS, INC.
1109.06.000
In Commercial Distribution

  • 00819251020381 ()

  • size 6


  • Orthopaedic broach

Klassic Blade Femoral Broach - 00819251020374

Blade Femoral Broach, size 5
TOTAL JOINT ORTHOPEDICS, INC.
1109.05.000
In Commercial Distribution

  • 00819251020374 ()

  • size 5


  • Orthopaedic broach

Klassic Blade Femoral Broach - 00819251020367

Blade Femoral Broach, size 4
TOTAL JOINT ORTHOPEDICS, INC.
1109.04.000
In Commercial Distribution

  • 00819251020367 ()

  • size 4


  • Orthopaedic broach

Klassic Blade Femoral Broach - 00819251020350

Blade Femoral Broach, size 3
TOTAL JOINT ORTHOPEDICS, INC.
1109.03.000
In Commercial Distribution

  • 00819251020350 ()

  • size 3


  • Orthopaedic broach

Klassic Blade Femoral Broach - 00819251020343

Blade Femoral Broach, size 2
TOTAL JOINT ORTHOPEDICS, INC.
1109.02.000
In Commercial Distribution

  • 00819251020343 ()

  • size 2


  • Orthopaedic broach

Klassic Blade Femoral Broach - 00819251020336

Blade Femoral Broach, size 1
TOTAL JOINT ORTHOPEDICS, INC.
1109.01.000
In Commercial Distribution

  • 00819251020336 ()

  • size 1


  • Orthopaedic broach

Klassic Blade Femoral Broach - 00819251020329

Blade Femoral Broach, size 0
TOTAL JOINT ORTHOPEDICS, INC.
1109.00.000
In Commercial Distribution

  • 00819251020329 ()

  • size 0


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020305

Modular Femoral Broach, size 9
TOTAL JOINT ORTHOPEDICS, INC.
1106.09.000
In Commercial Distribution

  • 00819251020305 ()

  • size 9


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020299

Modular Femoral Broach, size 8
TOTAL JOINT ORTHOPEDICS, INC.
1106.08.000
In Commercial Distribution

  • 00819251020299 ()

  • size 8


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020282

Modular Femoral Broach, size 7
TOTAL JOINT ORTHOPEDICS, INC.
1106.07.000
In Commercial Distribution

  • 00819251020282 ()

  • size 7


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020275

Modular Femoral Broach, size 6
TOTAL JOINT ORTHOPEDICS, INC.
1106.06.000
In Commercial Distribution

  • 00819251020275 ()

  • size 6


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020268

Modular Femoral Broach, size 5
TOTAL JOINT ORTHOPEDICS, INC.
1106.05.000
In Commercial Distribution

  • 00819251020268 ()

  • size 5


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020251

Modular Femoral Broach, size 4
TOTAL JOINT ORTHOPEDICS, INC.
1106.04.000
In Commercial Distribution

  • 00819251020251 ()

  • size 4


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020244

Modular Femoral Broach, size 3
TOTAL JOINT ORTHOPEDICS, INC.
1106.03.000
In Commercial Distribution

  • 00819251020244 ()

  • size 3


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020237

Modular Femoral Broach, size 2
TOTAL JOINT ORTHOPEDICS, INC.
1106.02.000
In Commercial Distribution

  • 00819251020237 ()

  • size 2


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020220

Modular Femoral Broach, size 1
TOTAL JOINT ORTHOPEDICS, INC.
1106.01.000
In Commercial Distribution

  • 00819251020220 ()

  • size 1


  • Orthopaedic broach

Klassic HD Modular Femoral Broach - 00819251020213

Modular Femoral Broach, size 0
TOTAL JOINT ORTHOPEDICS, INC.
1106.00.000
In Commercial Distribution

  • 00819251020213 ()

  • size 0


  • Orthopaedic broach

Femoral Broach - 00819251020107

Femoral Broach, Size 9
TOTAL JOINT ORTHOPEDICS, INC.
1100.09.000
In Commercial Distribution

  • 00819251020107 ()

  • Size 9


  • Orthopaedic broach

Femoral Broach - 00819251020091

Femoral Broach, Size 8
TOTAL JOINT ORTHOPEDICS, INC.
1100.08.000
In Commercial Distribution

  • 00819251020091 ()

  • Size 8


  • Orthopaedic broach

Femoral Broach - 00819251020084

Femoral Broach, Size 7
TOTAL JOINT ORTHOPEDICS, INC.
1100.07.000
In Commercial Distribution

  • 00819251020084 ()

  • Size 7


  • Orthopaedic broach

Femoral Broach - 00819251020077

Femoral Broach, Size 6
TOTAL JOINT ORTHOPEDICS, INC.
1100.06.000
In Commercial Distribution

  • 00819251020077 ()

  • Size 6


  • Orthopaedic broach

Femoral Broach - 00819251020060

Femoral Broach, Size 5
TOTAL JOINT ORTHOPEDICS, INC.
1100.05.000
In Commercial Distribution

  • 00819251020060 ()

  • Size 5


  • Orthopaedic broach

Femoral Broach - 00819251020053

Femoral Broach, Size 4
TOTAL JOINT ORTHOPEDICS, INC.
1100.04.000
In Commercial Distribution

  • 00819251020053 ()

  • Size 4


  • Orthopaedic broach

Femoral Broach - 00819251020046

Femoral Broach, Size 3
TOTAL JOINT ORTHOPEDICS, INC.
1100.03.000
In Commercial Distribution

  • 00819251020046 ()

  • Size 3


  • Orthopaedic broach

Femoral Broach - 00819251020039

Femoral Broach, Size 2
TOTAL JOINT ORTHOPEDICS, INC.
1100.02.000
In Commercial Distribution

  • 00819251020039 ()

  • Size 2


  • Orthopaedic broach

Femoral Broach - 00819251020022

Femoral Broach, Size 1
TOTAL JOINT ORTHOPEDICS, INC.
1100.01.000
In Commercial Distribution

  • 00819251020022 ()

  • Size 1


  • Orthopaedic broach

Femoral Broach - 00819251020015

Femoral Broach, Size 0
TOTAL JOINT ORTHOPEDICS, INC.
1100.00.000
In Commercial Distribution

  • 00819251020015 ()

  • Size 0


  • Orthopaedic broach

K-ASSAY® Total IgE Calibrator - 00816426020672

For the calibration of the K-ASSAY® Total IgE assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-093C
Not in Commercial Distribution

  • 00816426020672 ()
KAI-093C

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, calibrator

K-ASSAY® Total IgE Reagent - 00816426020375

For the quantitative determination of human total IgE in serum or plasma by immunoturbidimetric assay.
KAMIYA BIOMEDICAL COMPANY, LLC
KAI-092
Not in Commercial Distribution

  • 00816426020375 ()
KAI-092

  • Allergen-specific/total immunoglobulin E (IgE) antibody IVD, reagent

IRM - 10.0cc - 00813909013275

Synthetic bone void filler for orthopedic applications
NOVABONE PRODUCTS, LLC
NP0610SX
In Commercial Distribution

  • 00813909013275 ()

  • 10.0cc
NP0610SX

  • Bone matrix implant, synthetic, non-antimicrobial
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