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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4.0mm Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8040
In Commercial Distribution

  • 00840124518513 ()
TN-CS-8040

  • Bone screw fixation sleeve
3.5mm Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8035
In Commercial Distribution

  • 00840124518506 ()
TN-CS-8035

  • Bone screw fixation sleeve
3.0mm Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8030
In Commercial Distribution

  • 00840124518490 ()
TN-CS-8030

  • Bone screw fixation sleeve
2.5mm Tissue Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8025
In Commercial Distribution

  • 00840124518483 ()
TN-CS-8025

  • Bone screw fixation sleeve
1.6mm K-Wire Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8016
In Commercial Distribution

  • 00840124518476 ()
TN-CS-8016

  • Bone screw fixation sleeve
1.4mm K-Wire Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8014
In Commercial Distribution

  • 00840124518469 ()
TN-CS-8014

  • Bone screw fixation sleeve
0.9mm K-Wire Protector
FUSION ORTHOPEDICS, LLC
TN-CS-8009
In Commercial Distribution

  • 00840124518452 ()
TN-CS-8009

  • Bone screw fixation sleeve
Three Prong Right Offset Inserter (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-35I0-S
In Commercial Distribution

  • 00840124517813 ()
CD-DB-35I0-S

  • Orthopaedic bone staple driver
Cannulated Driver 2.5mm
FUSION ORTHOPEDICS, LLC
CD-CS-3025
In Commercial Distribution

  • 00840124514416 ()
CD-CS-3025

  • Surgical screwdriver, single-use
Cannulated Drill 2.5mm (1.7mm)
FUSION ORTHOPEDICS, LLC
CD-CS-1025
In Commercial Distribution

  • 00840124514393 ()
CD-CS-1025

  • Cannulated surgical drill bit, single-use
Three Prong T Offset Inserter (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-3OI0-S
In Commercial Distribution

  • 00840124513662 ()
CD-DB-3OI0-S

  • Orthopaedic bone staple driver
Three Prong T Inserter (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-3TI0-S
In Commercial Distribution

  • 00840124513655 ()
CD-DB-3TI0-S

  • Orthopaedic bone staple driver
Four Prong Straight Inserter (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-4SI0-S
In Commercial Distribution

  • 00840124513648 ()
CD-DB-4SI0-S

  • Orthopaedic bone staple driver
Four Prong T Inserter (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-4TI0-S
In Commercial Distribution

  • 00840124513631 ()
CD-DB-4TI0-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 14mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI14-S
In Commercial Distribution

  • 00840124513624 ()
CD-DB-CI14-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 12mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI12-S
In Commercial Distribution

  • 00840124513617 ()
CD-DB-CI12-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 10mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI10-S
In Commercial Distribution

  • 00840124513600 ()
CD-DB-CI10-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 8mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI08-S
In Commercial Distribution

  • 00840124513594 ()
CD-DB-CI08-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 6mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI06-S
In Commercial Distribution

  • 00840124513587 ()
CD-DB-CI06-S

  • Orthopaedic bone staple driver
Calc Slide Inserter 4mm (Sterile)
FUSION ORTHOPEDICS, LLC
CD-DB-CI04-S
In Commercial Distribution

  • 00840124513570 ()
CD-DB-CI04-S

  • Orthopaedic bone staple driver
Three Prong T Offset Inserter
FUSION ORTHOPEDICS, LLC
CD-DB-3OI0
In Commercial Distribution

  • 00840124513464 ()
CD-DB-3OI0

  • Orthopaedic bone staple driver
Three Prong T Inserter
FUSION ORTHOPEDICS, LLC
CD-DB-3TI0
In Commercial Distribution

  • 00840124513457 ()
CD-DB-3TI0

  • Orthopaedic bone staple driver
Four Prong Straight Inserter
FUSION ORTHOPEDICS, LLC
CD-DB-4SI0
In Commercial Distribution

  • 00840124513440 ()
CD-DB-4SI0

  • Orthopaedic bone staple driver
Four Prong T Inserter
FUSION ORTHOPEDICS, LLC
CD-DB-4TI0
In Commercial Distribution

  • 00840124513433 ()
CD-DB-4TI0

  • Orthopaedic bone staple driver
Calc Slide Inserter 14mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI14
In Commercial Distribution

  • 00840124513426 ()
CD-DB-CI14

  • Orthopaedic bone staple driver
Calc Slide Inserter 12mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI12
In Commercial Distribution

  • 00840124513419 ()
CD-DB-CI12

  • Orthopaedic bone staple driver
Calc Slide Inserter 10mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI10
In Commercial Distribution

  • 00840124513402 ()
CD-DB-CI10

  • Orthopaedic bone staple driver
Calc Slide Inserter 8mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI08
In Commercial Distribution

  • 00840124513396 ()
CD-DB-CI08

  • Orthopaedic bone staple driver
Calc Slide Inserter 6mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI06
In Commercial Distribution

  • 00840124513389 ()
CD-DB-CI06

  • Orthopaedic bone staple driver
Calc Slide Inserter 4mm
FUSION ORTHOPEDICS, LLC
CD-DB-CI04
In Commercial Distribution

  • 00840124513372 ()
CD-DB-CI04

  • Orthopaedic bone staple driver
Driver Torx FT 7.0mm
FUSION ORTHOPEDICS, LLC
CD-FT-3070
In Commercial Distribution

  • 00840124512795 ()
CD-FT-3070

  • Surgical screwdriver, single-use
Driver Torx FT 5.5mm
FUSION ORTHOPEDICS, LLC
CD-FT-3055
In Commercial Distribution

  • 00840124512788 ()
CD-FT-3055

  • Surgical screwdriver, single-use
HT 2X Driver (4.5mm)
FUSION ORTHOPEDICS, LLC
TN-2X-3045
In Commercial Distribution

  • 00840124511835 ()


  • Surgical screwdriver, single-use
HT 2X Driver (3.4mm)
FUSION ORTHOPEDICS, LLC
TN-2X-3034
In Commercial Distribution

  • 00840124511828 ()


  • Surgical screwdriver, single-use
HT 2X Driver (2.6mm)
FUSION ORTHOPEDICS, LLC
TN-2X-3026
In Commercial Distribution

  • 00840124511811 ()


  • Surgical screwdriver, single-use
HT 2X Thread Drill (2.2mm)
FUSION ORTHOPEDICS, LLC
CD-2X-1022
In Commercial Distribution

  • 00840124511804 ()


  • Cannulated surgical drill bit, single-use
HT 2X Thread Drill (2.0mm)
FUSION ORTHOPEDICS, LLC
CD-2X-1020
In Commercial Distribution

  • 00840124511798 ()


  • Cannulated surgical drill bit, single-use
Drill PEEK Anchor 4.75mm
FUSION ORTHOPEDICS, LLC
CD-TL-1045
In Commercial Distribution

  • 00840124511514 ()
CD-TL-1045

  • Cannulated surgical drill bit, single-use
3.5mm Drill PEEK Anchor
FUSION ORTHOPEDICS, LLC
CD-TL-1035
In Commercial Distribution

  • 00840124511507 ()


  • Cannulated surgical drill bit, single-use
Chamfered Screw Cannulated Drill 3.0mm (2.1mm)
FUSION ORTHOPEDICS, LLC
CD-CS-1030
In Commercial Distribution

  • 00840124510340 ()


  • Cannulated surgical drill bit, single-use
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