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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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Bioplate® - M3848135191

Straight Plate - Low-Profile - 2 hole - 11 mm [50 PK]
Bioplate, Inc.
81-3519
In Commercial Distribution

  • M3848135191 ()
  • M3848135190 ()

  • Length: 11 Millimeter
81-3519

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Bioplate® - M3848134880

Triangle Plate - Ø1.5 mm - 3 hole - 16 mm
Bioplate, Inc.
81-3488
In Commercial Distribution

  • M3848134880 ()

  • Length: 16 Millimeter
81-3488

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Shukla Spine-TL S9SPINE-TL,S9SPINE-CTL - SDR756SDR8830

Driver, Assy, 1/4' Square, for Medicrea Pass LP Screw
Shukla Medical
SDR883
In Commercial Distribution

  • SDR756SDR8830 ()


  • Surgical screwdriver, reusable

360CAS - B432360CAS00760

4mm Hex Driver Long
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0076
In Commercial Distribution

  • B432360CAS00760 ()


  • Robotic surgical navigation system application software

360CAS - B432360CAS00680

CAS Flex Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
KIC-DND-0068
In Commercial Distribution

  • B432360CAS00680 ()


  • Robotic surgical navigation system application software

Mallet - B114214000

Mallet used for cervical inter-vertebral body spacer placement
CALVARY SPINE, LLC
Mallet
In Commercial Distribution

  • B114214000 ()
214-00

  • Surgical mallet

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2HE000020

Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Driver Handle Extractor
Shoulder Innovations, Inc.
RSA Handle Extractor
In Commercial Distribution

  • B1132R2HE000020 ()
2R2HE00002

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2GT400200

Shoulder Innovations Inset Reverse Total Shoulder - RSA T20 Driver
Shoulder Innovations, Inc.
RSA T20 Driver
In Commercial Distribution

  • B1132R2GT400200 ()
2R2GT40020

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2GT400150

Shoulder Innovations Inset Reverse Total Shoulder - RSA T15 Driver
Shoulder Innovations, Inc.
RSA T15 Driver
In Commercial Distribution

  • B1132R2GT400150 ()
2R2GT40015

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable

Shoulder Innovations Inset Reverse Total Shoulder - B1132R2GT200000

Shoulder Innovations Inset Reverse Total Shoulder - RSA Screw Driver Handle
Shoulder Innovations, Inc.
RSA Screw Driver Handle
In Commercial Distribution

  • B1132R2GT200000 ()
2R2GT20000

  • Total shoulder prosthesis
  • Total reverse shoulder prosthesis
  • Orthopaedic prosthesis implantation positioning instrument, reusable
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