LEVEL ONE NEURO, STERILE

GUDID 00888118114600

MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM

KLS-Martin L.P.

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized

• Primary Device ID: 00888118114600
• NIH Device Record Key: c737a167-46e5-4c58-ba26-4d732f2f8a66
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LEVEL ONE NEURO, STERILE
• Version Model Number: 25-008-74-71
• Company DUNS: 826499238
• Company Name: KLS-Martin L.P.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com
• Phone: +1(904)641-7746
• Email: KLS-UDI-Info@klsmartin.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888118114600 [Primary]

FDA Product Code

• JEY: PLATE, BONE

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-21
• Device Publish Date: 2018-03-15

On-Brand Devices [LEVEL ONE NEURO, STERILE]

• 10888118106916: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106909: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106886: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106879: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106862: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106848: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106831: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106824: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106800: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106565: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106558: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106534: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106527: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106510: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106497: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106480: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106473: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
• 10888118106459: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
• 10888118048766: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 00888118121448: PLATE, MICRO, LADDER, 1.5 MM SCREW, CP TITANIUM
• 00888118114631: MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
• 00888118114624: MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
• 00888118114617: MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
• 00888118114600: MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
• 00888118114594: MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
• 00888118114587: MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
• 00888118114570: MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
• 00888118114563: MESH, 3D, ULTRAONE, NEURO SCREW, CP TITANIUM
• 00888118108609: KIT, CRANIOTOMY FLAP, 25-975-03-71 (12), 25-015-05-71 (3), CP TITANIUM / TI-6AL-4V
• 00888118106940: PLATE, ULTRAONE, Y SHP, W/TAB, NEURO SCREW, TI-6AL-4V
• 00888118106933: PLATE, ULTRAONE, X SHP, W/TAB, NEURO SCREW, TI-6AL-4V
• 00888118106926: SCREW, MAXDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
• 00888118106896: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 00888118106858: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 00888118106810: SCREW, MAXDRIVE, DRILL FREE, TI-6AL-4V
• 00888118106797: MESH, STANDARD, ULTRAONE, NEURO SCREW, CP TITANIUM
• 00888118106773: SCREW, ONEDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
• 00888118106766: SCREW, ONEDRIVE, DRILL FREE, EMERGENCY, TI-6AL-4V
• 00888118106759: PLATE, ULTRAONE, LADDER, CVD, W/TAB, NEURO SCREW, TI-6AL-4V
• 00888118106735: BURR HOLE COVER, ULTRAONE, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
• 00888118106711: PLATE, ULTRAONE, LADDER, W/TAB, NEURO SCREW, TI-6AL-4V
• 00888118106698: BURR HOLE COVER, ULTRAONE, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
• 00888118106681: BURR HOLE COVER, ULTRAONE, 105* DRAIN, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
• 00888118106667: BURR HOLE COVER, ULTRAONE, CONTOURED, W/TAB, NEURO SCREW, CP TITANIUM
• 00888118106643: PLATE, ULTRAONE, STR, W/TAB, NEURO SCREW, TI-6AL-4V
• 00888118106629: PLATE, ULTRAONE, STR, W/TAB, NEURO SCREW, TI-6AL-4V
• 00888118106612: PLATE, ULTRAONE, STR, W/TAB, NEURO SCREW, TI-6AL-4V
• 00888118106582: PLATE, ULTRAONE, DBL Y SHP, W/TAB, NEURO SCREW, TI-6AL-4V
• 00888118106544: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V
• 00888118106506: SCREW, ONEDRIVE, DRILL FREE, TI-6AL-4V