LEVEL ONE NEURO

GUDID 00888118131485

SCREW, ONEDRIVE, TI-6AL-4V

KLS-Martin L.P.

Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable, non-sterile Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable Craniofacial bone screw, non-bioabsorbable
Primary Device ID00888118131485
NIH Device Record Key203f3318-0113-49bd-a5cd-32fe7152e1b9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEVEL ONE NEURO
Version Model Number25-153-53-09
Company DUNS826499238
Company NameKLS-Martin L.P.
Device Count5
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com
Phone+1(904)641-7746
EmailKLS-UDI-Info@klsmartin.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100888118131485 [Unit of Use]
GS110888118131482 [Primary]

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


[00888118131485]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-02
Device Publish Date2022-02-22

On-Brand Devices [LEVEL ONE NEURO]

10888118102314SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118101430SCREW, ONEDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
10888118101270SCREW, ONEDRIVE, DRILL FREE, V2, TI-6AL-4V
10888118101263SCREW, ONEDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
10888118101256SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118075342SCREW, MAXDRIVE, TENTING, TI-6AL-4V
10888118075328SCREW, MAXDRIVE, TENTING, TI-6AL-4V
10888118048827SCREW, MAXDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
10888118048803SCREW, MAXDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
10888118048780SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
10888118048759SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
10888118048742SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
10888118046595SCREW, ULTRA LOW PROFILE, EMERGENCY, TI-6AL-4V
10888118046571SCREW, ULTRA LOW PROFILE, EMERGENCY, TI-6AL-4V
10888118046557SCREW, ULTRA LOW PROFILE, TI-6AL-4V
10888118046533SCREW, ULTRA LOW PROFILE, TI-6AL-4V
10888118046410SCREW, CROSSDRIVE, TI-6AL-4V
00888118113948PLATE, ULTRAONE, TEMPORALIS, RIGHT, COMBINATION, NEURO SCREW, CP TITANIUM
00888118113931PLATE, ULTRAONE, TEMPORALIS, LEFT, COMBINATION, NEURO SCREW, CP TITANIUM
00888118113030SCREW, MAXDRIVE, TENTING, TI-6AL-4V
00888118113023SCREW, MAXDRIVE, TENTING, TI-6AL-4V
00888118113009SCREW, MAXDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
00888118112996SCREW, MAXDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
00888118112989SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
00888118112972SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
00888118112965SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
00888118111821SCREW, ULTRA LOW PROFILE, EMERGENCY, TI-6AL-4V
00888118111814SCREW, ULTRA LOW PROFILE, EMERGENCY, TI-6AL-4V
00888118111807SCREW, ULTRA LOW PROFILE, TI-6AL-4V
00888118111791SCREW, ULTRA LOW PROFILE, TI-6AL-4V
00888118111784SCREW, CROSSDRIVE, TI-6AL-4V
00888118110718SCREW, ONEDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
00888118110701SCREW, ONEDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
00888118110695SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
00888118110688SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
00888118110671SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
00888118106780MESH, STANDARD, ULTRAONE, W/TAB, NEURO SCREW, CP TITANIUM
00888118106742PLATE, ULTRAONE, LADDER, CVD, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106728BURR HOLE COVER, ULTRAONE, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
00888118106704PLATE, ULTRAONE, LADDER, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106674BURR HOLE COVER, ULTRAONE, 105* DRAIN, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
00888118106650BURR HOLE COVER, ULTRAONE, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
00888118106636PLATE, ULTRAONE, STR, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106605PLATE, ULTRAONE, STR, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106599PLATE, ULTRAONE, Y SHP, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106575PLATE, ULTRAONE, DBL Y SHP, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106438PLATE, ULTRAONE, STR, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106421PLATE, ULTRAONE, X SHP, W/TAB, NEURO SCREW, TI-6AL-4V
00888118102300MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
00888118102294MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM

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