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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MALLET 50MM 10.25"PLASTIC
SKLAR CORPORATION
40-5792
In Commercial Distribution

  • 10649111338618 ()


  • Surgical mallet
MALLET 45MM 10.25"PLASTIC
SKLAR CORPORATION
40-5791
In Commercial Distribution

  • 10649111338427 ()


  • Surgical mallet
MALLET 35MM 10.25"PLASTIC
SKLAR CORPORATION
40-5790
In Commercial Distribution

  • 10649111338243 ()


  • Surgical mallet
SCREW DRIVER FOR 4.5MM
SKLAR CORPORATION
40-1663
In Commercial Distribution

  • 10649111094422 ()


  • Surgical screwdriver, reusable
SCREW DRIVR FOR HEX HEAD 3.5MM
SKLAR CORPORATION
40-1659
In Commercial Distribution

  • 10649111093838 ()


  • Surgical screwdriver, reusable
SCREW DRIVER FOR DEFORMED HEX
SKLAR CORPORATION
40-1654
In Commercial Distribution

  • 10649111093166 ()


  • Surgical screwdriver, reusable
SINGLE SLOT SCREWDRIVER 10 INCHES
SKLAR CORPORATION
40-1625
In Commercial Distribution

  • 10649111088339 ()


  • Surgical screwdriver, reusable
SCREWDRIVER 1.5MM HEX 9 3/4 INCHES
SKLAR CORPORATION
40-1623
In Commercial Distribution

  • 10649111087950 ()


  • Surgical screwdriver, reusable
T22 Self-retaining Driver
SPINECRAFT, LLC
6300-22-3
In Commercial Distribution

  • M82463002231 ()
6300-22-3

  • General internal orthopaedic fixation system implantation kit
VELOX Screwdriver, with Solid Pin, Regular Length Driver
SPINECRAFT, LLC
4020-05-SP
In Commercial Distribution

  • M824402005SP1 ()
4020-05-SP

  • General internal orthopaedic fixation system implantation kit
SCREW DRIVR FOR HEX HEAD 2.5MM
SKLAR CORPORATION
40-1658
In Commercial Distribution

  • 10649111093708 ()


  • Surgical screwdriver, reusable
SCREW DRIVER T-BAR 180MM
SKLAR CORPORATION
40-1653
In Commercial Distribution

  • 10649111093036 ()


  • Surgical screwdriver, reusable
LANE SCREW DRIVER FLAT HEAD
SKLAR CORPORATION
40-1652
In Commercial Distribution

  • 10649111092909 ()


  • Surgical screwdriver, reusable
SCREW DRIVER W/SHERMN PN 215MM
SKLAR CORPORATION
40-1651
In Commercial Distribution

  • 10649111092695 ()


  • Surgical screwdriver, reusable
LANE SCREW DRIVER CROSS SLOT
SKLAR CORPORATION
40-1650
In Commercial Distribution

  • 10649111092619 ()


  • Surgical screwdriver, reusable
SCREW DRIVER PHILIPS 8 INCHES
SKLAR CORPORATION
40-1641
In Commercial Distribution

  • 10649111091186 ()


  • Surgical screwdriver, reusable
SCREW DRIVER CROSS SLIT 9 3/4 INCHES
SKLAR CORPORATION
40-1640
In Commercial Distribution

  • 10649111091018 ()


  • Surgical screwdriver, reusable
SINGLE SLOT SCREWDRIVER 6.75 INCHES
SKLAR CORPORATION
40-1626
In Commercial Distribution

  • 10649111088490 ()


  • Surgical screwdriver, reusable
ASTRA T22 Hexalobe Driver
SPINECRAFT, LLC
6300-22-M
In Commercial Distribution

  • M824630022M1 ()
6300-22-M

  • General internal orthopaedic fixation system implantation kit
VELOX Screwdriver, with Solid Pin, Short Length Driver
SPINECRAFT, LLC
4020-05-SPS
In Commercial Distribution

  • M824402005SPS1 ()
4020-05-SPS

  • General internal orthopaedic fixation system implantation kit
SCREWDRIVER TUBE
SpineArt SA
ELL-IN 21 03-N
In Commercial Distribution

  • 07640139349934 ()
ELL-IN 21 03-N

  • Surgical screwdriver, reusable
SCREWDRIVER SLEEVE
SpineArt SA
ELL-IN 20 03-N
In Commercial Distribution

  • 07640139349927 ()
ELL-IN 20 03-N

  • Surgical screwdriver, reusable
SETSCREW TIGHTENER
SpineArt SA
ELL-IN 04 06-N
In Commercial Distribution

  • 07640139349910 ()
ELL-IN 04 06-N

  • Surgical screwdriver, reusable
DYNAMOMETRIC TIGHTENER
SpineArt SA
ELL-IN 03 06-N
In Commercial Distribution

  • 07640139349903 ()
ELL-IN 03 06-N

  • Surgical screwdriver, reusable
Revision screwdriver
SpineArt SA
PAD-IN 07 00-N
In Commercial Distribution

  • 07640139349323 ()
PAD-IN 07 00-N

  • Surgical screwdriver, reusable
Nut for Pins
SpineArt SA
CDP-IN 30 02-N
In Commercial Distribution

  • 07640139343192 ()
CDP-IN 30 02-N

  • Surgical screwdriver, reusable
IMPLANT HOLDER
SpineArt SA
CDP-IN 00 01-N
In Commercial Distribution

  • 07640139343055 ()
CDP-IN 00 01-N

  • Surgical implant/trial-implant/sizer holder, reusable
SETSCREW TIGHTENER
SpineArt SA
ELL-IN 00 06-N
In Commercial Distribution

  • 07640139342041 ()
ELL-IN 00 06-N

  • Surgical screwdriver, reusable
SCREWDRIVER 2.5
SpineArt SA
MOS-IN 00 03-N
In Commercial Distribution

  • 07640139340573 ()
MOS-IN 00 03-N

  • Surgical screwdriver, reusable
No Description
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
00-7050-042-00
In Commercial Distribution

  • 00889024311466 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
00-7050-039-00
In Commercial Distribution

  • 00889024311435 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
00-5887-056-00
In Commercial Distribution

  • 00889024310810 ()
00-5887-056-00

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
00-4215-200-00
In Commercial Distribution

  • 00889024306332 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
9200-01-006
Not in Commercial Distribution

  • 00889024176560 ()


  • Surgical instrument handle, non-torque-limiting
No Description
Zimmer, Inc.
9200-01-005
Not in Commercial Distribution

  • 00889024176553 ()


  • Surgical instrument handle, non-torque-limiting
Cervical SA Straight Driver
Nanohive Medical LLC
C-A-0014
In Commercial Distribution

  • 00817493024501 ()
C-A-0014

  • Surgical screwdriver, reusable
Cervical SA Angled Driver
Nanohive Medical LLC
C-A-0013
In Commercial Distribution

  • 00817493024495 ()
C-A-0013

  • Surgical screwdriver, reusable
Cross Connector Driver, Torque Limiting, Axial, 12 in/lbs.
Wishbone Medical, Inc.
62-2679-00
Not in Commercial Distribution

  • B562090675NS0 ()
62-2679-00

  • Surgical torque wrench, reusable
Cross Connector Driver, Torque Limiting, Axial, 12 in/lbs.
Wishbone Medical, Inc.
09.0675
Not in Commercial Distribution

  • B5620906750 ()
09.0675

  • Surgical torque wrench, reusable
Handle, T, Ratchet, 1/4 sq.
Wishbone Medical, Inc.
62-2671-31
Not in Commercial Distribution

  • B562090655NS0 ()
62-2671-31

  • Surgical torque wrench adaptor
Handle, T, Ratchet, 1/4 sq.
Wishbone Medical, Inc.
09.0655
Not in Commercial Distribution

  • B5620906550 ()
09.0655

  • Surgical torque wrench adaptor
AO Drill Bit 4.8 x 200mm - Non-Sterile
Wishbone Medical, Inc.
00-6200-48-WBNS
Not in Commercial Distribution

  • B56200620048WBNS0 ()


  • Cannulated surgical drill bit, single-use, non-sterile
AO Drill Bit 3.2 x 200mm - Non-Sterile
Wishbone Medical, Inc.
00-6200-32-WBNS
Not in Commercial Distribution

  • B56200620032WBNS0 ()


  • Cannulated surgical drill bit, single-use, non-sterile
10mm Hex Bolt Socket - Non-Sterile
Wishbone Medical, Inc.
00-2155-10-WB
Not in Commercial Distribution

  • B56200215510WB0 ()
00-2155-10-WB

  • External orthopaedic fixation system, reusable
13mm Hex Bolt Wrench - Non-Sterile
Wishbone Medical, Inc.
00-2055-13-WB
Not in Commercial Distribution

  • B56200205513WB0 ()
00-2055-13-WB

  • External orthopaedic fixation system, reusable
10mm Hex Bolt Wrench - Non-Sterile
Wishbone Medical, Inc.
00-2055-10-WB
Not in Commercial Distribution

  • B56200205510WB0 ()
00-2055-10-WB

  • External orthopaedic fixation system, reusable
10mm Socket Wrench - Non-Sterile
Wishbone Medical, Inc.
00-2055-10S-WB
Not in Commercial Distribution

  • B56200205510SWB0 ()
00-2055-10S-WB

  • External orthopaedic fixation system, reusable
10mm Hex Bolt Ratchet Wrench - Non-Sterile
Wishbone Medical, Inc.
00-2055-10R-WB
Not in Commercial Distribution

  • B56200205510RWB0 ()
00-2055-10R-WB

  • External orthopaedic fixation system, reusable
5.4Nm Torque Limiting Ratchet Wrench - Non-Sterile
Wishbone Medical, Inc.
00-2055-08-WB
Not in Commercial Distribution

  • B56200205508WB0 ()
00-2055-08-WB

  • External orthopaedic fixation system, reusable
Slotted Wrench - Non-Sterile
Wishbone Medical, Inc.
00-2054-10-WB
Not in Commercial Distribution

  • B56200205410WB0 ()
00-2054-10-WB

  • External orthopaedic fixation system, reusable
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