LEVEL ONE NEURO, STERILE

GUDID 00888118131492

SCREW, ONEDRIVE, TI-6AL-4V

KLS-Martin L.P.

Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, sterile Craniofacial bone screw, non-bioabsorbable, 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
Primary Device ID00888118131492
NIH Device Record Keycc567879-3e54-4240-9664-57080a7a8926
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEVEL ONE NEURO, STERILE
Version Model Number25-153-54-74
Company DUNS826499238
Company NameKLS-Martin L.P.
Device Count4
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 Datetrue
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

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100888118131492 [Unit of Use]
GS110888118131499 [Primary]

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

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

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10888118106886SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
10888118106879SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
10888118106862SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
10888118106848SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
10888118106831SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
10888118106824SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
10888118106800SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
10888118106565SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118106558SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118106534SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118106527SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118106510SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118106497SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118106480SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118106473SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118106459SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
10888118048766SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
00888118121448PLATE, MICRO, LADDER, 1.5 MM SCREW, CP TITANIUM
00888118114631MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
00888118114624MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
00888118114617MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
00888118114600MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
00888118114594MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
00888118114587MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
00888118114570MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
00888118114563MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
00888118108609KIT, CRANIOTOMY FLAP, 25-975-03-71 (12), 25-015-05-71 (3), CP TITANIUM / TI-6AL-4V
00888118106940PLATE, ULTRAONE, Y SHP, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106933PLATE, ULTRAONE, X SHP, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106926SCREW, MAXDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
00888118106896SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
00888118106858SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
00888118106810SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
00888118106797MESH, STANDARD, ULTRAONE, NEURO SCREW, CP TITANIUM
00888118106773SCREW, ONEDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
00888118106766SCREW, ONEDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
00888118106759PLATE, ULTRAONE, LADDER, CVD, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106735BURR HOLE COVER, ULTRAONE, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
00888118106711PLATE, ULTRAONE, LADDER, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106698BURR HOLE COVER, ULTRAONE, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
00888118106681BURR HOLE COVER, ULTRAONE, 105* DRAIN, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
00888118106667BURR HOLE COVER, ULTRAONE, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
00888118106643PLATE, ULTRAONE, STR, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106629PLATE, ULTRAONE, STR, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106612PLATE, ULTRAONE, STR, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106582PLATE, ULTRAONE, DBL Y SHP, W/TAB, NEURO SCREW, TI-6AL-4V
00888118106544SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
00888118106506SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V

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