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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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R E-CIMA Vitamin E PS Tibial Insert Sz B 14mm
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523143337 ()
1201-233-314

  • Posterior-stabilized total knee prosthesis
R E-CIMA Vitamin E PS Tibial Insert Sz B 12mm
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523143320 ()
1201-233-312

  • Posterior-stabilized total knee prosthesis
R E-CIMA Vitamin E PS Tibial Insert Sz B 10mm
KYOCERA MEDICAL TECHNOLOGIES, INC.
A 200
In Commercial Distribution

  • 00841523143313 ()
1201-233-310

  • Posterior-stabilized total knee prosthesis
Superelastic Nitinol 4 Prong T-Implant Syle B 30mm x 16mm
FUSION ORTHOPEDICS, LLC
DB-4P-3016-B
In Commercial Distribution

  • 00840124513334 ()
DB-4P-3016-B

  • Orthopaedic bone staple, non-adjustable
REFLECTION XLPE 22 0 DEG LATERALIZED +4 42 B ETO
Smith & Nephew, Inc.
71334551
In Commercial Distribution

  • 00885556020104 ()
71334551

  • Ceramic acetabular liner
No Description
Biomet Orthopedics, LLC
110024460
In Commercial Distribution

  • 00880304703483 ()

  • 36 mm Bearing Size Liner Size B
110024460

  • Metallic acetabular liner
No Description
Biomet Orthopedics, LLC
110017100
In Commercial Distribution

  • 00880304672079 ()

  • 46 mm Shell Size Liner Size B
110017100

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
010000991
In Commercial Distribution

  • 00880304527393 ()

  • 22.2mm Head Size 36mm Bearing Size B
010000991

  • Non-constrained polyethylene acetabular liner
No Description
Biomet Orthopedics, LLC
010000660
In Commercial Distribution

  • 00880304524194 ()

  • 46 mm Shell Size Liner Size B
010000660

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
11-301332
In Commercial Distribution

  • 00880304474642 ()

  • B SIZE 70 MM TYPE 1 TAPER
11-301332

  • Coated femoral stem prosthesis, modular
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