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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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PolyLock Ankle - 00840124508606

Utility Straight Plate, 9 Hole
FUSION ORTHOPEDICS, LLC
AK-UP-0009
In Commercial Distribution

  • 00840124508606 ()
AK-UP-0009

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

MedSource Flex-All Splint - 00840155408296

Flex All Splint Orange - 9"
MEDSOURCE INTERNATIONAL LLC
MS-SPLINT-9
In Commercial Distribution

  • 00840155408296 ()
Not Applicable

  • First aid limb splint, mouldable, reusable

PolyLock Ankle - 00840124508378

Medial Malleolus Plate, 9 Hole
FUSION ORTHOPEDICS, LLC
AK-MM-1009
In Commercial Distribution

  • 00840124508378 ()
AK-MM-1009

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

PolyLock Ankle Plates - 00840124505513

Utility Straight Plate 9 Hole
FUSION ORTHOPEDICS, LLC
AK-UP-0009
In Commercial Distribution

  • 00840124505513 ()
AK-UP-0009

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

PolyLock Ankle Plates - 00840124505285

Medial Malleolus Plate 9 Hole
FUSION ORTHOPEDICS, LLC
AK-MM-1009
In Commercial Distribution

  • 00840124505285 ()
AK-MM-1009

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Avalign - 00190776059286

Mallet 9 oz, 5oz head
Avalign Technologies, Inc.
VM104-1326
In Commercial Distribution

  • 00190776059286 ()


  • Surgical mallet

Needle Holder - 10840199540393

Ryder Needle Holder 23cm 9"
KOROS U.S.A., INC.
9640-09
In Commercial Distribution

  • 00840199540396 ()
  • 10840199540393 ()

  • 9x12mm
9640-09

  • Suturing needle holder, reusable

Needle Holder - 10840199540300

Mayo-Hegar Needle Holders 23cm 9"
KOROS U.S.A., INC.
9620-09
In Commercial Distribution

  • 00840199540303 ()
  • 10840199540300 ()

  • 9x12mm
9620-09

  • Suturing needle holder, reusable

Needle Holder - 10840199540249

Crile-Wood Needle Holders 23cm 9"
KOROS U.S.A., INC.
9610-09
In Commercial Distribution

  • 00840199540242 ()
  • 10840199540249 ()

  • 9x12mm
9610-09

  • Suturing needle holder, reusable

Needle Holder - 10840199540478

DeBakey Needle Holder 23cm 9"
KOROS U.S.A., INC.
9650-09
In Commercial Distribution

  • 00840199540471 ()
  • 10840199540478 ()

  • 9x12mm
9650-09

  • Suturing needle holder, reusable
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