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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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Monkey Rings™ External Fixation System - 00889795120960

Case 3 K-Wire Caddy
Paragon 28, Inc.
P45-903-CAD1
In Commercial Distribution

  • 00889795120960 ()
P45-903-CAD1

  • Device sterilization/disinfection container, reusable

Monkey Rings™ External Fixation System - 00889795120953

Tubular Wrench, 10mm
Paragon 28, Inc.
P45-513-0004
In Commercial Distribution

  • 00889795120953 ()
P45-513-0004

  • Surgical torque wrench, reusable

Monkey Rings™ External Fixation System - 00889795120915

Case Base, Case 2 of 4
Paragon 28, Inc.
P45-902-BASE
In Commercial Distribution

  • 00889795120915 ()
P45-902-BASE

  • Device sterilization/disinfection container, reusable

Monkey Rings™ External Fixation System - 00889795120908

Case Dishwasher, Case 1 of 4
Paragon 28, Inc.
P45-901-DISH
In Commercial Distribution

  • 00889795120908 ()
P45-901-DISH

  • Device sterilization/disinfection container, reusable

Paragon 28 Bone Wedge System - 00889795120540

AO 2.2MM DRILL BIT
Paragon 28, Inc.
AOHT22
In Commercial Distribution

  • 00889795120540 ()
AOHT22

  • Cannulated surgical drill bit, reusable

Paragon 28 Bone Wedge System - 00889795120533

AO 2.0MM DRILL BIT
Paragon 28, Inc.
AOHT20
In Commercial Distribution

  • 00889795120533 ()
AOHT20

  • Cannulated surgical drill bit, reusable

APEX 3D Total Ankle Replacement System - 00889795118516

APEX 3D-PS Total Ankle Replacement System, Dorsal Talar Recut Guide, 4mm Large
Paragon 28, Inc.
P10-844-04LG
In Commercial Distribution

  • 00889795118516 ()
P10-844-04LG

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795118509

APEX 3D-PS Total Ankle Replacement System, Dorsal Talar Recut Guide, 4mm Small
Paragon 28, Inc.
P10-844-04SM
In Commercial Distribution

  • 00889795118509 ()
P10-844-04SM

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795118493

APEX 3D-PS Total Ankle Replacement System, Dorsal Talar Recut Guide, 2mm Large
Paragon 28, Inc.
P10-844-02LG
In Commercial Distribution

  • 00889795118493 ()
P10-844-02LG

  • Osteotomy guide, reusable

APEX 3D Total Ankle Replacement System - 00889795118486

APEX 3D-PS Total Ankle Replacement System, Dorsal Talar Recut Guide, 2mm Small
Paragon 28, Inc.
P10-844-02SM
In Commercial Distribution

  • 00889795118486 ()
P10-844-02SM

  • Osteotomy guide, reusable
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