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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FINAL DRIVER, ROD-TO-ROD CROSSLINK
Pioneer Surgical Technology, Inc.
26-R2R-XLINK-DRVR
Not in Commercial Distribution

  • 00846468054601 ()


  • General internal orthopaedic fixation system implantation kit
Driver Bit
Pioneer Surgical Technology, Inc.
86-DRIVERBIT-2
Not in Commercial Distribution

  • 00846468053918 ()
86-DRIVERBIT-2

  • Sternal fixation device
Screw Driver
Pioneer Surgical Technology, Inc.
86-DRIVER-2
Not in Commercial Distribution

  • 00846468053901 ()
86-DRIVER-2

  • Sternal fixation device
SCREW DRIVER
Pioneer Surgical Technology, Inc.
27-DRIVER
Not in Commercial Distribution

  • 00846468053000 ()


  • General internal orthopaedic fixation system implantation kit
PIN DRIVER
Pioneer Surgical Technology, Inc.
27-PIN-DRIVER
Not in Commercial Distribution

  • 00846468051631 ()


  • General internal orthopaedic fixation system implantation kit
Re-Entry Driver
Pioneer Surgical Technology, Inc.
86-RE-ENTRYDRV
Not in Commercial Distribution

  • 00846468064181 ()
86-RE-ENTRYDRV

  • Sternal fixation device
Mallet
Pioneer Surgical Technology, Inc.
55-MALLET
Not in Commercial Distribution

  • 00846468063795 ()
55-MALLET

  • Surgical mallet
CONICAL ABUT RET SCREW 5HD 1CH TI USE 2MM INTERNAL HEX DRIVER
ACE SURGICAL SUPPLY CO., INC.
19509501
In Commercial Distribution

  • 00614950004409 ()

  • Width: 5 Millimeter
19509501

  • Screw endosteal dental implant, one-piece
CONICAL ABUT RET SCREW 4HD 2CH TI USE 2MM INTERNAL HEX DRIVER
ACE SURGICAL SUPPLY CO., INC.
19509002
In Commercial Distribution

  • 00614950004379 ()

  • Width: 4 Millimeter
19509002

  • Screw endosteal dental implant, one-piece
CONICAL ABUT RET SCREW 4HD 1CH TI USE 2MM INTERNAL HEX DRIVER
ACE SURGICAL SUPPLY CO., INC.
19509001
In Commercial Distribution

  • 00614950004362 ()

  • Width: 4 Millimeter
19509001

  • Screw endosteal dental implant, one-piece
Inserter Shaft with Stop
Pioneer Surgical Technology, Inc.
30-CC-INSRTSHAFT-S
Not in Commercial Distribution

  • 00846468062712 ()


  • General internal orthopaedic fixation system implantation kit
Inserter Shaft
Pioneer Surgical Technology, Inc.
30-CC-INSRTSHAFT
Not in Commercial Distribution

  • 00846468062705 ()


  • General internal orthopaedic fixation system implantation kit
Inserter Body
Pioneer Surgical Technology, Inc.
30-CC-INSERTER
Not in Commercial Distribution

  • 00846468062699 ()


  • General internal orthopaedic fixation system implantation kit
Final Driver, Extended
Pioneer Surgical Technology, Inc.
21-EXTDFINALDRV-TL
Not in Commercial Distribution

  • 00846468062682 ()
21-EXTDFINALDRV-TL

  • Orthopaedic inorganic implant inserter/extractor, reusable
Universal screw driver
UNITED ORTHOPEDIC CORP.
9601-1213-RD
In Commercial Distribution

  • 04719872179368 ()
9601-1213-RD

  • Surgical screwdriver, reusable
Universal screw driver
UNITED ORTHOPEDIC CORP.
9601-1213
In Commercial Distribution

  • 04719872179351 ()
9601-1213

  • Surgical screwdriver, reusable
Screw driver, straight
UNITED ORTHOPEDIC CORP.
9601-1212
In Commercial Distribution

  • 04719872179344 ()

  • straight
9601-1212

  • Surgical screwdriver, reusable
Sliding hammer
UNITED ORTHOPEDIC CORP.
9101-1203
In Commercial Distribution

  • 04719872179054 ()
9101-1203

  • Surgical mallet
Tibial baseplate driver
UNITED ORTHOPEDIC CORP.
9403-5101
In Commercial Distribution

  • 04719872178750 ()
9403-5101

  • Orthopaedic inorganic implant inserter/extractor, reusable
Screw driver, flexible
UNITED ORTHOPEDIC CORP.
9601-1201
In Commercial Distribution

  • 04719872177616 ()

  • flexible
9601-1201

  • Surgical screwdriver, reusable
Screw driver, HEX 5
UNITED ORTHOPEDIC CORP.
9404-1701
In Commercial Distribution

  • 04719872177265 ()

  • HEX 5
9404-1701

  • Surgical screwdriver, reusable
Screw driver adaptor, T20
UNITED ORTHOPEDIC CORP.
9403-5331-RA
In Commercial Distribution

  • 04719872176824 ()

  • T20
9403-5331-RA

  • Surgical screwdriver, reusable
Tibial baseplate driver
UNITED ORTHOPEDIC CORP.
9403-5101-RC
In Commercial Distribution

  • 04719872176633 ()
9403-5101-RC

  • Orthopaedic inorganic implant inserter/extractor, reusable
Driver handle, 3/8"
UNITED ORTHOPEDIC CORP.
9403-1302-RA
In Commercial Distribution

  • 04719872175995 ()

  • 3/8"
9403-1302-RA

  • Surgical instrument handle, non-torque-limiting
Screw driver
UNITED ORTHOPEDIC CORP.
9401-5307
In Commercial Distribution

  • 04719872175865 ()
9401-5307

  • Surgical screwdriver, reusable
Quick pin driver
UNITED ORTHOPEDIC CORP.
9304-5105
In Commercial Distribution

  • 04719872175599 ()
9304-5105

  • Orthopaedic implant-instrument extension adaptor, reusable
Slotted hammer
UNITED ORTHOPEDIC CORP.
9304-5104
In Commercial Distribution

  • 04719872175582 ()
9304-5104

  • Surgical mallet
Femoral driver
UNITED ORTHOPEDIC CORP.
9304-5101
In Commercial Distribution

  • 04719872175551 ()
9304-5101

  • Orthopaedic inorganic implant inserter/extractor, reusable
Screw driver
UNITED ORTHOPEDIC CORP.
9304-1102
In Commercial Distribution

  • 04719872175384 ()
9304-1102

  • Surgical screwdriver, reusable
Screw duiver adaptor, L, T20
UNITED ORTHOPEDIC CORP.
9303-5329
In Commercial Distribution

  • 04719872175247 ()

  • L, T20
9303-5329

  • Surgical screwdriver, reusable
Sliding hammer
UNITED ORTHOPEDIC CORP.
9303-5311
In Commercial Distribution

  • 04719872175186 ()
9303-5311

  • Surgical mallet
Chamfer guide extractor
UNITED ORTHOPEDIC CORP.
9303-5301
In Commercial Distribution

  • 04719872175162 ()
9303-5301

  • Surgical mallet
Inserter Fork, Large
Pioneer Surgical Technology, Inc.
32-EL-INSRTFORK-LG
Not in Commercial Distribution

  • 00846468066505 ()


  • General internal orthopaedic fixation system implantation kit
Inserter Fork, Medium
Pioneer Surgical Technology, Inc.
32-EL-INSRTFORK-MD
Not in Commercial Distribution

  • 00846468066499 ()


  • General internal orthopaedic fixation system implantation kit
Inserter Fork, Small
Pioneer Surgical Technology, Inc.
32-EL-INSRTFORK, SM
Not in Commercial Distribution

  • 00846468066482 ()


  • General internal orthopaedic fixation system implantation kit
Inserter
Pioneer Surgical Technology, Inc.
32-EL-INSERTER
Not in Commercial Distribution

  • 00846468066475 ()


  • General internal orthopaedic fixation system implantation kit
CONICAL ABUT RET SCREW 5HD 2CH TI USE 2MM INTERNAL HEX DRIVER
ACE SURGICAL SUPPLY CO., INC.
19509502
In Commercial Distribution

  • 00614950004416 ()

  • Width: 5 Millimeter
19509502

  • Screw endosteal dental implant, one-piece
HEX DRIVER, 3.5mm
Pioneer Surgical Technology, Inc.
405-696
Not in Commercial Distribution

  • 00846468041045 ()
405-696

  • General internal orthopaedic fixation system implantation kit
Torque Driver
Pioneer Surgical Technology, Inc.
400-908
Not in Commercial Distribution

  • 00846468040932 ()


  • Internal spinal fixation system cable
DRIVER EX0411334 6.35 PROV. T-HANDLE
MEDTRONIC SOFAMOR DANEK, INC.
EX0411334
In Commercial Distribution

  • 00613994997487 ()


  • Orthopaedic implant driver
Femoral driver
UNITED ORTHOPEDIC CORP.
9303-5110-RD
In Commercial Distribution

  • 04719872175056 ()
9303-5110-RD

  • Orthopaedic inorganic implant inserter/extractor, reusable
Femoral driver
UNITED ORTHOPEDIC CORP.
9303-5110-RB
In Commercial Distribution

  • 04719872175049 ()
9303-5110-RB

  • Orthopaedic inorganic implant inserter/extractor, reusable
Femoral driver
UNITED ORTHOPEDIC CORP.
9303-5110
In Commercial Distribution

  • 04719872175032 ()
9303-5110

  • Orthopaedic inorganic implant inserter/extractor, reusable
Femoral driver
UNITED ORTHOPEDIC CORP.
9303-5102
In Commercial Distribution

  • 04719872174974 ()
9303-5102

  • Orthopaedic inorganic implant inserter/extractor, reusable
Spike and Tibial EM guide extractor
UNITED ORTHOPEDIC CORP.
9303-5101
In Commercial Distribution

  • 04719872174967 ()
9303-5101

  • Surgical mallet
External rotation guide driver
UNITED ORTHOPEDIC CORP.
9303-5023
In Commercial Distribution

  • 04719872174950 ()
9303-5023

  • Surgical instrument handle, non-torque-limiting
Quick pin driver
UNITED ORTHOPEDIC CORP.
9303-5001-RA
In Commercial Distribution

  • 04719872174936 ()
9303-5001-RA

  • Orthopaedic implant-instrument extension adaptor, reusable
Stem trial driver
UNITED ORTHOPEDIC CORP.
9303-1101
In Commercial Distribution

  • 04719872174202 ()
9303-1101

  • Orthopaedic implant-instrument extension adaptor, reusable
Universal screw driver
UNITED ORTHOPEDIC CORP.
9206-1114
In Commercial Distribution

  • 04719872173908 ()
9206-1114

  • Surgical screwdriver, reusable
Straight screw driver
UNITED ORTHOPEDIC CORP.
9206-1113
In Commercial Distribution

  • 04719872173892 ()
9206-1113

  • Surgical screwdriver, reusable
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