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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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RESORB XG, STERILE - 00888118085603

BURR HOLE COVER, 0.5 MM CONTOUR, PLLA-PGA
KLS-Martin L.P.
52-812-24-04
In Commercial Distribution

  • 00888118085603 ()

  • 5 HOLE, 22 MM DIA, T=1.0 MM


  • Craniofacial fixation plate, bioabsorbable

Arthrex® - 00888867336599

4.0MM CANNULATED DRILL
ARTHREX, INC.
AR-1360D
In Commercial Distribution

  • 00888867336599 ()
AR-1360D

  • Cannulated surgical drill bit, single-use

NA - 00763000210199

ACCY 3550S-01 STIMLOC BURR HOLE CVR KIT
MEDTRONIC, INC.
3550S-01
In Commercial Distribution

  • 00763000210199 ()


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

HawkOne™ - 00763000202699

ATHERECTOMY H1-14550 CUTTER DRIVER US
Covidien LP
H1-14550
In Commercial Distribution

  • 00763000202699 ()


  • Mechanical atherectomy system catheter, peripheral

XCALIBER BONE SCREWS - 18054242512646

BONE SCREW HAND DRILL STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242512646 ()
99-91120

  • External orthopaedic fixation system, reusable

Galaxy Fixation System - 18054242511670

SMALL MULTISCREW CLAMP-SHORT STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242511670 ()
99-93330

  • External orthopaedic fixation system, reusable

Galaxy Fixation System - 18054242511663

SMALL MULTISCREW CLAMP-LONG STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242511663 ()
99-93320

  • External orthopaedic fixation system, reusable

Galaxy Fixation System - 18054242511526

MEDIUM MULTISCREW CLAMP STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242511526 ()
99-93120

  • External orthopaedic fixation system, reusable

Galaxy Fixation System - 18054242511519

LARGE-MEDIUM TRANSITION CLAMP STERILE
ORTHOFIX SRL
1
In Commercial Distribution

  • 18054242511519 ()
99-93030

  • External orthopaedic fixation system, reusable

ORTHOFIX - 18053800898598

SS T10 EXTRACTION SCREWDRIVER
ORTHOFIX SRL
1
In Commercial Distribution

  • 18053800898598 ()

  • Cone size: T10
99-154341

  • Surgical screwdriver, reusable
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