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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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Medtronic Reusable Instruments - 00613994918482

DRIVER EX1110243 EXTENDER
MEDTRONIC SOFAMOR DANEK, INC.
EX1110243
In Commercial Distribution

  • 00613994918482 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994917966

DRIVER EX1110238 2.5 MM FLEX SCREWSHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX1110238
In Commercial Distribution

  • 00613994917966 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994915696

DRIVER X1110185 PROVISIONAL
MEDTRONIC SOFAMOR DANEK, INC.
X1110185
In Commercial Distribution

  • 00613994915696 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994909145

DRIVER EX1110154 T27 NON BREAKOFF
MEDTRONIC SOFAMOR DANEK, INC.
EX1110154
In Commercial Distribution

  • 00613994909145 ()


  • Surgical instrument handle, non-torque-limiting

Medtronic Reusable Instruments - 00613994909107

DRIVER X1110200 GENERAL SS SHORT MAS
MEDTRONIC SOFAMOR DANEK, INC.
X1110200
In Commercial Distribution

  • 00613994909107 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994907431

DRIVER EX09103796 TWISTED T-25
MEDTRONIC SOFAMOR DANEK, INC.
EX09103796
In Commercial Distribution

  • 00613994907431 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994906939

DRIVER EX1110065 3.5MM CAPTIV TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX1110065
In Commercial Distribution

  • 00613994906939 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994906373

DRIVER EX07101322 3.5MM TWIST HEX
MEDTRONIC SOFAMOR DANEK, INC.
EX07101322
In Commercial Distribution

  • 00613994906373 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994906366

SCREWDRIVER EX07101321 T25
MEDTRONIC SOFAMOR DANEK, INC.
EX07101321
In Commercial Distribution

  • 00613994906366 ()


  • Orthopaedic implant driver

POWEREASE™ Instruments - 00613994905734

POST CUTTER 2346020 POST CUTTER
MEDTRONIC SOFAMOR DANEK, INC.
2346020
In Commercial Distribution

  • 00613994905734 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905727

SCREWDRIVER 2342306M 5.5 MAS
MEDTRONIC SOFAMOR DANEK, INC.
2342306M
In Commercial Distribution

  • 00613994905727 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905710

SCREWDRIVER 2342306L 5.5 MAS
MEDTRONIC SOFAMOR DANEK, INC.
2342306L
In Commercial Distribution

  • 00613994905710 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905703

SCREWDRIVER 2342305S 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
2342305S
In Commercial Distribution

  • 00613994905703 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905697

SCREWDRIVER 2342305M 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
2342305M
In Commercial Distribution

  • 00613994905697 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905680

SCREWDRIVER 2342305L 4.75 MAS
MEDTRONIC SOFAMOR DANEK, INC.
2342305L
In Commercial Distribution

  • 00613994905680 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905673

SCREWDRIVER 2342301S 5.5 RMAS
MEDTRONIC SOFAMOR DANEK, INC.
2342301S
In Commercial Distribution

  • 00613994905673 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905666

SCREWDRIVER 2342301M 5.5 RMAS
MEDTRONIC SOFAMOR DANEK, INC.
2342301M
In Commercial Distribution

  • 00613994905666 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905659

SCREWDRIVER 2342301L 5.5 RMAS
MEDTRONIC SOFAMOR DANEK, INC.
2342301L
In Commercial Distribution

  • 00613994905659 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905642

SCREWDRIVER 2342300S 4.75 RMAS
MEDTRONIC SOFAMOR DANEK, INC.
2342300S
In Commercial Distribution

  • 00613994905642 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905635

SCREWDRIVER 2342300M 4.75 RMAS
MEDTRONIC SOFAMOR DANEK, INC.
2342300M
In Commercial Distribution

  • 00613994905635 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905628

SCREWDRIVER 2342300L 4.75 RMAS
MEDTRONIC SOFAMOR DANEK, INC.
2342300L
In Commercial Distribution

  • 00613994905628 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905611

SCREWDRIVER 2342281S 5.5 FAS
MEDTRONIC SOFAMOR DANEK, INC.
2342281S
In Commercial Distribution

  • 00613994905611 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905604

SCREWDRIVER 2342281M 5.5 FAS
MEDTRONIC SOFAMOR DANEK, INC.
2342281M
In Commercial Distribution

  • 00613994905604 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905598

SCREWDRIVER 2342281L 5.5 FAS
MEDTRONIC SOFAMOR DANEK, INC.
2342281L
In Commercial Distribution

  • 00613994905598 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905581

SCREWDRIVER 2342306S 5.5 MAS
MEDTRONIC SOFAMOR DANEK, INC.
2342306S
In Commercial Distribution

  • 00613994905581 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905536

SLEEVE 2343429M 8.0MM NIM SLEEVE
MEDTRONIC SOFAMOR DANEK, INC.
2343429M
In Commercial Distribution

  • 00613994905536 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905451

SCREWDRIVER 2342326M THREADED POST
MEDTRONIC SOFAMOR DANEK, INC.
2342326M
In Commercial Distribution

  • 00613994905451 ()


  • Surgical screwdriver, reusable

POWEREASE™ Instruments - 00613994905444

SCREWDRIVER 2342326L THREADED POST
MEDTRONIC SOFAMOR DANEK, INC.
2342326L
In Commercial Distribution

  • 00613994905444 ()


  • Surgical screwdriver, reusable

Medtronic Reusable Instruments - 00613994900968

SCREWDRIVER EX1010909 T27 REDUCTION
MEDTRONIC SOFAMOR DANEK, INC.
EX1010909
In Commercial Distribution

  • 00613994900968 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994900913

SLEEVE EX1010850 DRIVER 105MM LENGTH
MEDTRONIC SOFAMOR DANEK, INC.
EX1010850
In Commercial Distribution

  • 00613994900913 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994897794

DRIVER EX1010172 CLOSED MAS
MEDTRONIC SOFAMOR DANEK, INC.
EX1010172
In Commercial Distribution

  • 00613994897794 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994895110

DRIVER EX0810531 3.5MM HEX SHORTER
MEDTRONIC SOFAMOR DANEK, INC.
EX0810531
Not in Commercial Distribution

  • 00613994895110 ()


  • Orthopaedic implant driver

Medtronic Reusable Instruments - 00613994895073

DRIVER EX1010181 3.2MM TAPERED HEX SHORT
MEDTRONIC SOFAMOR DANEK, INC.
EX1010181
In Commercial Distribution

  • 00613994895073 ()


  • Orthopaedic implant driver

Streamline TL Spinal Fixation System - 00846468001582

DRIVER, ROD TO ROD
Xtant Medical Holdings, Inc.
10-RDDRIVER
Not in Commercial Distribution

10-RDDRIVER

  • Surgical screwdriver, reusable

USTAR II Knee System - 04711605589871

Set screw driver adaptor, T8
UNITED ORTHOPEDIC CORP.
9315-5101-RB
In Commercial Distribution

  • 04711605589871 ()


  • Orthopaedic implant-instrument extension adaptor, reusable

USTAR II Knee System - 04711605589864

Driver handle, 1/4", SQ
UNITED ORTHOPEDIC CORP.
9315-1103
In Commercial Distribution

  • 04711605589864 ()


  • Surgical instrument handle, non-torque-limiting

"USTAR II Knee System " - 04711605589543

USTAR II Tibial baseplate driver
UNITED ORTHOPEDIC CORP.
9415-5005
In Commercial Distribution

  • 04711605589543 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

USTAR II Knee System - 04711605589178

Femoral driver
UNITED ORTHOPEDIC CORP.
9315-5110
In Commercial Distribution

  • 04711605589178 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

USTAR II Knee System - 04711605589925

Insert screw driver adaptor
UNITED ORTHOPEDIC CORP.
9315-5106
In Commercial Distribution

  • 04711605589925 ()


  • Orthopaedic implant-instrument extension adaptor, reusable

USTAR II Knee System - 04711605589536

USTAR II Tibial baseplate trial driver
UNITED ORTHOPEDIC CORP.
9415-5004
In Commercial Distribution

  • 04711605589536 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

USTAR II Knee System - 04711605584982

Screw driver adaptor, T30
UNITED ORTHOPEDIC CORP.
9415-5101
In Commercial Distribution

  • 04711605584982 ()
9415-5101

  • Surgical screwdriver, reusable

U2 Total Knee System - 04711605583763

Femoral driver
UNITED ORTHOPEDIC CORP.
9303-5110-RT
In Commercial Distribution

  • 04711605583763 ()
9303-5110-RT

  • Orthopaedic inorganic implant inserter/extractor, reusable

UKNEE Total Knee System - 04711605582674

Slide hammer assembly
UNITED ORTHOPEDIC CORP.
9301-5105
In Commercial Distribution

  • 04711605582674 ()
9301-5105

  • Surgical mallet

Orthopedic manual surgical instrument - 04718005159871

Comet Lumbar Implant Driver
BAUI BIOTECH CO. LTD.
420-1724
In Commercial Distribution

  • 04718005159871 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

Orthopedic manual surgical instrument - 04718005155231

3mm Hex Screw Driver
BAUI BIOTECH CO. LTD.
406-0830A
In Commercial Distribution

  • 04718005155231 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable

CirFIX® Cranial bone fixation system: Burr Hole Cover - 04717002404335

CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type for Shunt & ICP+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9906.0014.11S
In Commercial Distribution

  • 04717002404335 ()
  • 14717002404332 ()
  • 24717002404339 ()
9906.0014.11S

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

CirFIX® Cranial bone fixation system: Burr Hole Cover - 04717002404328

CUSMED CirFIX® Burr Hole Cover, Radiolucent Revisable Type+Screwdriver, PEEK, 14mm/11mm, Sterile
OSSAWARE BIOTECH CO., LTD.
9905.0014.11S
In Commercial Distribution

  • 14717002404325 ()
  • 04717002404328 ()
  • 24717002404322 ()
9905.0014.11S

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

Quantum® Spinal Fixation System - 00846468022297

DRIVER, X-LINK®
Pioneer Surgical Technology, Inc.
10-XLINKDRIVER
Not in Commercial Distribution

  • 00846468022297 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468022181

DRIVER, TORQUE LIMITING
Pioneer Surgical Technology, Inc.
10-TLHANDLE
Not in Commercial Distribution

  • 00846468022181 ()


  • General internal orthopaedic fixation system implantation kit

Quantum® Spinal Fixation System - 00846468021610

DRIVER, ROD TO ROD
Pioneer Surgical Technology, Inc.
10-RDDRIVER
Not in Commercial Distribution

  • 00846468021610 ()


  • General internal orthopaedic fixation system implantation kit
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