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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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Buxton BioMedical - B7687211050

Penfield 5 Dissector, 290x7&8
Buxton Biomedical Inc
72-1105
In Commercial Distribution

  • B7687211050 ()
72-1105

  • Hand-held surgical retractor, reusable

Buxton Biomedical - B7685676050

Mini-Lexer Gouge, 5 mm wide
Buxton Biomedical Inc
56-7605
In Commercial Distribution

  • B7685676050 ()
56-7605

  • Surgical gouge

Buxton BioMedical - B7685151080

Jeweler's Forceps #5, ang 45°
Buxton Biomedical Inc
51-5108
In Commercial Distribution

  • B7685151080 ()
51-5108

  • Dressing/utility forceps, tweezers-like, reusable

Optimotion Blue CR HCCR Total Knee System - B6961014240050

Tibial Tray Trial Sz 5
OPTIMOTION IMPLANTS LLC
1014-2-4005
In Commercial Distribution

  • B6961014240050 ()


  • Joint prosthesis implantation kit, reusable

Optimotion Blue CR HCCR Total Knee System - B6961014230050

Tibial Tray Template Sz 5
OPTIMOTION IMPLANTS LLC
1014-2-3005
In Commercial Distribution

  • B6961014230050 ()


  • Joint prosthesis implantation kit, reusable

Optimotion Blue CR HCCR Total Knee System - B6961014120050

Femoral Trial Universal Sz 5
OPTIMOTION IMPLANTS LLC
1014-1-2005
In Commercial Distribution

  • B6961014120050 ()


  • Joint prosthesis implantation kit, reusable

HI-I® - B715070250480

Special Fibered #5 HI-I®
FRICKE INTERNATIONAL, INC.
07025-048
In Commercial Distribution

  • B715070250480 ()

  • Weight: 48 Gram
07025-048

  • Dental appliance fabrication material, resin

HI-I® - B71507025025P0

Special Fibered #5 HI-I®
FRICKE INTERNATIONAL, INC.
07025-025P
In Commercial Distribution

  • B71507025025P0 ()

  • Weight: 25 Pound
07025-025P

  • Dental appliance fabrication material, resin

HI-I® - B71507025006P0

Special Fibered #5 HI-I®
FRICKE INTERNATIONAL, INC.
07025-006P
In Commercial Distribution

  • B71507025006P0 ()

  • Weight: 6 Pound
07025-006P

  • Dental appliance fabrication material, resin

HI-I® - B715070250060

Special Fibered #5 HI-I®
FRICKE INTERNATIONAL, INC.
07025-006
In Commercial Distribution

  • B715070250060 ()

  • Weight: 145 Gram
07025-006

  • Dental appliance fabrication material, resin
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