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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No Description
ARTHREX, INC.
2.7mm x 16mm MINI-CRX Self-Tapping, Bone Screw
Not in Commercial Distribution

  • 00816988012160 ()
SC2716-FST

  • Clavicle intramedullary nail-like rod
No Description
ARTHREX, INC.
2.7mm x 14mm MINI-CRX Self-Tapping, Bone Screw
Not in Commercial Distribution

  • 00816988012153 ()
SC2714-FST

  • Clavicle intramedullary nail-like rod
No Description
ARTHREX, INC.
MINI-CRX®3.2x110mm
Not in Commercial Distribution

  • 00816988012139 ()
FST-32110

  • Clavicle intramedullary nail-like rod
No Description
ARTHREX, INC.
MINI-CRX®3.2x90mm
Not in Commercial Distribution

  • 00816988012115 ()
FST-32090

  • Clavicle intramedullary nail-like rod
No Description
ARTHREX, INC.
MINI-CRX®3.2x80mm
Not in Commercial Distribution

  • 00816988012108 ()
FST-32080

  • Clavicle intramedullary nail-like rod
No Description
ARTHREX, INC.
4.0mmx40mm Partially Threaded Cannulated Cancellous Screw
Not in Commercial Distribution

  • 00816988012092 ()
CA4040-C

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
ARTHREX, INC.
Instrument Case Lid
Not in Commercial Distribution

  • 00816988012054 ()
IN6802

  • Device sterilization/disinfection container, reusable
No Description
ARTHREX, INC.
Instrument Case Inner Tray
Not in Commercial Distribution

  • 00816988012047 ()
IN6801

  • Device sterilization/disinfection container, reusable
No Description
ARTHREX, INC.
Instrument Case
Not in Commercial Distribution

  • 00816988012030 ()
IN6800

  • Device sterilization/disinfection container, reusable
4.0mm Long Cannulated Reamer, strl
ARTHREX, INC.
CS6140-LC
Not in Commercial Distribution

  • 00816988012016 ()
CS6140-LC

  • Cannulated surgical drill bit, single-use
No Description
ARTHREX, INC.
Attachment Screw
Not in Commercial Distribution

  • 00816988011958 ()
CS6910

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
ARTHREX, INC.
1.25mm x 6" K-Wire
Not in Commercial Distribution

  • 00816988011934 ()
CS6013-6

  • Orthopaedic bone wire
No Description
ARTHREX, INC.
1.6mm x 12" K-Wire
Not in Commercial Distribution

  • 00816988011927 ()
CS6016-12

  • Orthopaedic bone wire
No Description
ARTHREX, INC.
2.5mm Syndesmotic Drill
Not in Commercial Distribution

  • 00816988011910 ()
CS6125

  • Orthopaedic bone wire
1.25/2.7mm Drill Guide
ARTHREX, INC.
IN6330
Not in Commercial Distribution

  • 00816988011903 ()
IN6330

  • Surgical drill guide, reusable
Screw Length Gauge
ARTHREX, INC.
IN6610
Not in Commercial Distribution

  • 00816988011897 ()
IN6610

  • Surgical drill guide, reusable
No Description
ARTHREX, INC.
2.5mm Cannulated Hex Driver
Not in Commercial Distribution

  • 00816988011880 ()
IN6225-C

  • Surgical screwdriver, reusable
No Description
ARTHREX, INC.
Reduction Forceps
Not in Commercial Distribution

  • 00816988011873 ()
IN6520

  • Bone approximation clamp
No Description
ARTHREX, INC.
Hintermann Distractor
Not in Commercial Distribution

  • 00816988011866 ()
IN6510

  • Orthopaedic surgical distractor, internal
No Description
ARTHREX, INC.
2.5mm Captive Hex Driver
Not in Commercial Distribution

  • 00816988011859 ()
IN6225

  • Surgical screwdriver, reusable
Double Sided Tissue Protector
ARTHREX, INC.
IN6300
Not in Commercial Distribution

  • 00816988011842 ()
IN6300

  • Surgical drill guide, reusable
Compression Driver
ARTHREX, INC.
IN6040
Not in Commercial Distribution

  • 00816988011835 ()
IN6040

  • Orthopaedic bone-fragment manipulator, reusable
Outrigger Impact Cap
ARTHREX, INC.
IN6030
Not in Commercial Distribution

  • 00816988011828 ()
IN6030

  • Orthopaedic implant impactor, reusable
Implant Insertion Guide
ARTHREX, INC.
IN6400
Not in Commercial Distribution

  • 00816988011811 ()
IN6400

  • Orthopaedic implantation sleeve, single-use
Guidewire Inserter
ARTHREX, INC.
IN6310
Not in Commercial Distribution

  • 00816988011804 ()
IN6310

  • Surgical drill guide, reusable
2.5mm Syndesmotic Drill Guide
ARTHREX, INC.
IN6125
Not in Commercial Distribution

  • 00816988011798 ()
IN6125

  • Surgical drill guide, reusable
Drill Guide Sleeve
ARTHREX, INC.
IN6050
Not in Commercial Distribution

  • 00816988011774 ()
IN6050

  • Surgical drill guide, reusable
Compression Screw Guide
ARTHREX, INC.
IN6010
Not in Commercial Distribution

  • 00816988011750 ()
IN6010

  • Surgical drill guide, reusable
No Description
ARTHREX, INC.
3.5mmx60mm Double Lead Cortical Bone Screw
Not in Commercial Distribution

  • 00816988011576 ()
CO3560-D

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
ARTHREX, INC.
3.5mmx55mm Double Lead Cortical Bone Screw
Not in Commercial Distribution

  • 00816988011569 ()
CO3555-D

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
ARTHREX, INC.
3.5mmx45mm Double Lead Cortical Bone Screw
Not in Commercial Distribution

  • 00816988011545 ()
CO3545-D

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
ARTHREX, INC.
3.5mmx40mm Double Lead Cortical Bone Screw
Not in Commercial Distribution

  • 00816988011538 ()
CO3540-D

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
3.0X180MM FIBULA NAIL, RIGHT
ARTHREX, INC.
FIB30180R
Not in Commercial Distribution

  • 00816988011521 ()
FIB30180R

  • Orthopaedic bone pin, non-bioabsorbable
3.0X180MM FIBULA NAIL, LEFT
ARTHREX, INC.
FIB30180L
Not in Commercial Distribution

  • 00816988011514 ()
FIB30180L

  • Orthopaedic bone pin, non-bioabsorbable
3.0X130MM FIBULA NAIL, RIGHT
ARTHREX, INC.
FIB30130R
Not in Commercial Distribution

  • 00816988011507 ()
FIB30130R

  • Orthopaedic bone pin, non-bioabsorbable
3.0X130MM FIBULA NAIL, LEFT
ARTHREX, INC.
FIB30130L
Not in Commercial Distribution

  • 00816988011491 ()
FIB30130L

  • Orthopaedic bone pin, non-bioabsorbable
3.8X180MM FIBULA NAIL, RIGHT
ARTHREX, INC.
FIB38180R
Not in Commercial Distribution

  • 00816988011484 ()
FIB38180R

  • Orthopaedic bone pin, non-bioabsorbable
3.8X180MM FIBULA NAIL, LEFT
ARTHREX, INC.
FIB38180L
Not in Commercial Distribution

  • 00816988011477 ()
FIB38180L

  • Orthopaedic bone pin, non-bioabsorbable
3.8X130MM FIBULA NAIL, RIGHT
ARTHREX, INC.
FIB38130R
Not in Commercial Distribution

  • 00816988011460 ()
FIB38130R

  • Orthopaedic bone pin, non-bioabsorbable
3.8x130MM FIBULA NAIL, LEFT
ARTHREX, INC.
FIB38130L
Not in Commercial Distribution

  • 00816988011453 ()
FIB38130L

  • Orthopaedic bone pin, non-bioabsorbable
No Description
ARTHREX, INC.
CRx DISPOSABLE INTRUMENTS PACKAGE
Not in Commercial Distribution

  • 00816988011446 ()
ST0101_A

  • Surgical drill guide, single-use
  • Orthopaedic bone wire
  • Cannulated surgical drill bit, single-use
No Description
ARTHREX, INC.
CRx DISPOSABLE REMOVAL KIT
Not in Commercial Distribution

  • 00816988011415 ()
ST0090

  • Orthopaedic inorganic implant inserter/extractor, reusable
REUSABLE OUTRIGGER RAIL
ARTHREX, INC.
IN0148
Not in Commercial Distribution

  • 00816988011354 ()
IN0148

  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
ARTHREX, INC.
Reusable Lateral Insertion Guide
Not in Commercial Distribution

  • 00816988011330 ()
CS0080-G

  • Orthopaedic implantation sleeve, reusable
2.5mm Captive Hex Driver Assembly
ARTHREX, INC.
IN0163
Not in Commercial Distribution

  • 00816988011293 ()
IN0163

  • Surgical screwdriver, reusable
4.5mm Reamer Sheath
ARTHREX, INC.
IN0051
Not in Commercial Distribution

  • 00816988011262 ()
IN0051

  • Surgical drill guide, reusable
4.5mm Awl / Aimer
ARTHREX, INC.
IN0145
Not in Commercial Distribution

  • 00816988011255 ()
IN0145

  • Bone awl, reusable
Solid External Sheath
ARTHREX, INC.
IN0165
Not in Commercial Distribution

  • 00816988011248 ()
IN0165

  • Surgical drill guide, reusable
No Description
ARTHREX, INC.
2.7mm x 34mm Self-Tapping,Sterile Bone Screw
Not in Commercial Distribution

  • 00816988011231 ()
SC2734-S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
No Description
ARTHREX, INC.
2.7mm x 32mm Self-Tapping,Sterile Bone Screw
Not in Commercial Distribution

  • 00816988011224 ()
SC2732-S

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
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