DISTRACTION, EXTERNAL

GUDID 00888118082688

KLS-Martin L.P.

Surgical torque wrench, reusable
Primary Device ID00888118082688
NIH Device Record Key210c0dbb-d808-44ee-83dc-9d948799aba6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDISTRACTION, EXTERNAL
Version Model Number51-580-87-07
Company DUNS826499238
Company NameKLS-Martin L.P.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(904)641-7746
Email[email protected]

Device Identifiers

Device Issuing AgencyDevice ID
GS100888118082688 [Primary]

FDA Product Code

HXCWRENCH

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888118082688]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2018-09-26

On-Brand Devices [DISTRACTION, EXTERNAL]

10888118099621SPINDLE, RED 2, SLEEK, ADJ, STAINLESS STEEL
10888118083385PIN, DRILL FREE, TI-6AL-4V
10888118083378PIN, DRILL FREE, TI-6AL-4V
10888118083361PIN, DRILL FREE, TI-6AL-4V
10888118083354PIN, DRILL FREE, TI-6AL-4V
10888118083347PIN, DRILL FREE, TI-6AL-4V
10888118082289SCREW, HEX, RED 2, HALO FIXATION, SMOOTH, SILVER, CP TITANIUM
10888118082265SCREW, HEX, RED 2, HALO FIXATION, SMOOTH, SILVER, CP TITANIUM
00888118121752LOCK NUT, 3DX, GORDON, TI-6AL-4V
00888118113481CLAMP, 3DX, PIN HOLDING W/SET SCREW, TI-6AL-4V
00888118113474DIST, MANDIBLE, 3DX, GORDON, 2.0-2.7 MM PIN, TI-6AL-4V
00888118108593PLATE, RED 2, MIDFACE FIXATION, V SHP, 1.5-1.8 MM SCREW, CP TITANIUM
00888118108463SCREW, HEX, RED 2, HALO FIXATON, DRILL FREE, HOPPER, SMOOTH, SILVER, CP TITANIUM
00888118108456SCREW, HEX, RED 2, HALO FIXATON, DRILL FREE, HOPPER, SMOOTH, SILVER, CP TITANIUM
00888118108029PIN, DRILL FREE, TI-6AL-4V
00888118108012PIN, DRILL FREE, TI-6AL-4V
00888118108005PIN, DRILL FREE, TI-6AL-4V
00888118107992PIN, DRILL FREE, TI-6AL-4V
00888118107985PIN, DRILL FREE, TI-6AL-4V
00888118103970PLATE, RED 2, MIDFACE FIXATION, BURTON, 1.5-1.8 MM SCREW, CP TITANIUM
00888118102126HORIZONTAL CROSS BAR ASSEMBLY, RED 2, COMPLETE, BLACK, ALUMINUM / STAINLESS STEEL
00888118102102SEGMENT, RED 3, RIGHT, ALUMINUM
00888118102096SEGMENT, RED 3, LEFT, ALUMINUM
00888118102089HORIZONTAL CROSS BAR, RED 3, CARBON
00888118102058HOLDER, RED 2, FOR HORIZONTAL CROSS BAR, BLACK, ALUMINUM
00888118102041UPPER PART, RED 2, BLACK, ALUMINUM
00888118102034SEGMENT, RED 2, RIGHT, BLACK, ALUMINUM
00888118102027SEGMENT, RED 2, LEFT, BLACK, ALUMINUM
00888118102010SPINDLE, RED 2, SLEEK, ADJ, STAINLESS STEEL
00888118101129LOCK NUT, 3DX, GORDON, TI-6AL-4V
00888118099891PLATE, RED 2, RETENTION, STURMAN, T LONG, 90*, W/GROOVE, 1.5-1.8 MM SCREW, STAINLESS STEEL ASTM F138
00888118099860HORIZONTAL CROSS BAR, RED 2, HOLLOW, STAINLESS STEEL
00888118099846DIST, RED 3, PEDIATRIC, SILVER, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INLCLUDES:51-585-01-04, 51-585-02-04, 51-580-05-04, 51-580-35-04, 51-585-70-04, 51-585-12-04, 51-575-30-09, 51-580-30-04, AND 51-580-85-07
00888118099839DIST, RED 2, ROUNDED FIXATION, PURPLE, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:51-583-01-04, 51-583-02-04, 51-580-05-04, 51-580-35-04, 51-575-15-04, 51-575-16-04, 51-575-30-09, 51-580-30-04, AND 51-580-85-07
00888118099822DIST, RED 2, PURPLE, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:51-580-01-04, 51-580-02-04, 51-580-05-04, 51-580-35-04, 51-575-15-04, 51-575-16-04, 51-575-30-09, 51-580-30-04, AND 51-580-85-07
00888118099815DIST, RED 2, GREEN, LESS SCREWS AND O/R SCREWDRIVER
00888118099808DIST, RED 2, GOLD, LESS SCREWS & O/R SCREWDRIVER
00888118099792DIST, RED 2, RED, LESS SCREWS & O/R SCREWDRIVER
00888118099785DIST, RED 2, SILVER, LESS SCREWS AND O/R SCREWDRIVER
00888118099778DIST, RED 2, BLACK, LESS SCREWS AND O/R SCREWDRIVER, PACKAGE INCLUDES:51-579-01-04, 51-579-02-04, 51-579-05-04, 51-579-35-04, 51-575-15-04, 51-575-16-04, 51-575-30-09, 51-580-30-04, AND 51-580-85-07
00888118099723DIST, RED 2, ROUNDED FIXATION, PURPLE, LESS SCREWS AND O/R SCREWDRIVER
00888118095244SCREW, HEX, RED 2, TRIAL POSITIONING, KNURLED, FOR HALO, BLUE, TI-6AL-4V
00888118095206PLATE, RED 2, TLTS, RETENTION, T LONG, S CVD, 2.0-2.3 MM SCREW, TI-6AL-4V
00888118093141LOCK NUT, 3DX, GORDON, TI-6AL-4V
00888118093097SCREW, HEX, RED 2, HALO FIXATION, DRILL FREE, HOPPER, SMOOTH, SILVER, CP TITANIUM
00888118092861DIST, MANDIBLE, MOLINA, BIDIRECT, RIGHT, 3.2 MM PIN, TI-6AL-4V
00888118092854DIST, MANDIBLE, MOLINA, BIDIRECT, RIGHT, 2.7 MM PIN, TI-6AL-4V
00888118092847DIST, MANDIBLE, MOLINA, BIDIRECT, LEFT, 2.7 MM PIN, TI-6AL-4V
00888118092830DIST, MANDIBLE, MOLINA, BIDIRECT, LEFT, 2.7 MM PIN, TI-6AL-4V
00888118092816HORIZONTAL CROSS BAR ASSEMBLY, RED 2, COMPLETE, SILVER

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