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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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Monster Screw System - 00889795040565

Over Drill, 2.0 x 110mm, Cannulated, AO
Paragon 28, Inc.
P99-110-2011
In Commercial Distribution

  • 00889795040565 ()
P99-110-2011

  • Cannulated surgical drill bit, single-use

Monster Screw System - 00889795040558

Drill, 1.7 x 120mm, Cannulated, AO
Paragon 28, Inc.
P99-110-1712
In Commercial Distribution

  • 00889795040558 ()
P99-110-1712

  • Cannulated surgical drill bit, single-use

HammerTube System - 00889795039446

Drill, 2.75mm, Cannulated (Patent Pending)
Paragon 28, Inc.
P40-920-2707
In Commercial Distribution

  • 00889795039446 ()
P40-920-2707

  • Cannulated surgical drill bit, single-use

HammerTube System - 00889795039439

Drill, 2.65mm, Cannulated (Patent Pending)
Paragon 28, Inc.
P40-920-2607
In Commercial Distribution

  • 00889795039439 ()
P40-920-2607

  • Cannulated surgical drill bit, single-use

HammerTube System - 00889795039422

Drill, 2.15mm, Cannulated (Patent Pending)
Paragon 28, Inc.
P40-920-2107
In Commercial Distribution

  • 00889795039422 ()
P40-920-2107

  • Cannulated surgical drill bit, single-use

N/A - 10705034479316

MODIFIED INSTRUMENT DRIVER 5.5MM
DEPUY SPINE, LLC
698341675
In Commercial Distribution

  • 10705034479316 ()


  • Surgical screwdriver, reusable

VELYS - 10705034643267

VELYS™ SCREWDRIVER T20
Medos International Sàrl
451611037
In Commercial Distribution

  • 10705034643267 ()
451611037

  • Surgical screwdriver, reusable

APEX 3D Total Ankle Replacement System - 00889795140630

Right Angle Drill - Hex Socket Driver
Paragon 28, Inc.
P11-854-RAD1-17
In Commercial Distribution

  • 00889795140630 ()
P11-854-RAD1-17

  • Surgical screwdriver, reusable

APEX 3D S Total Ankle Replacement System - 00889795140562

Short Stem Tibia, Instrument, Drill Bit, Tall, D10.5 x H14
Paragon 28, Inc.
P11-854-D10T
In Commercial Distribution

  • 00889795140562 ()
P11-854-D10T

  • Cannulated surgical drill bit, single-use

APEX 3D S Total Ankle Replacement System - 00889795140548

Short Stem Tibia, Instrument, Drill Bit, Tall, D9 x H14
Paragon 28, Inc.
P11-854-D09T
In Commercial Distribution

  • 00889795140548 ()
P11-854-D09T

  • Cannulated surgical drill bit, single-use
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