REVLOK

GUDID 00849044069891

8.5mm REVLOK 5.5 Screw, 35mm

GLOBUS MEDICAL, INC.

Trans-facet-screw internal spinal fixation system, sterile

• Primary Device ID: 00849044069891
• NIH Device Record Key: 810a31d0-76ef-49b2-8d48-8664f744f6f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVLOK
• Version Model Number: 178.632
• Company DUNS: 139105691
• Company Name: GLOBUS MEDICAL, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(610)930-1800
• Email: info@globusmedical.com

Device Dimensions

• Outer Diameter: 8.5 Millimeter
• Outer Diameter: 8.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00849044069891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110280

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[00849044069891]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-06

On-Brand Devices [REVLOK]

• 00849044070521: 8.5mm REVLOK HA 5.5 Screw, 90mm
• 00849044070514: 8.5mm REVLOK HA 5.5 Screw, 85mm
• 00849044070507: 8.5mm REVLOK HA 5.5 Screw, 80mm
• 00849044070491: 8.5mm REVLOK HA 5.5 Screw, 75mm
• 00849044070484: 8.5mm REVLOK HA 5.5 Screw, 70mm
• 00849044070477: 8.5mm REVLOK HA 5.5 Screw, 65mm
• 00849044070460: 8.5mm REVLOK HA 5.5 Screw, 60mm
• 00849044070453: 8.5mm REVLOK HA 5.5 Screw, 55mm
• 00849044070446: 8.5mm REVLOK HA 5.5 Screw, 50mm
• 00849044070439: 8.5mm REVLOK HA 5.5 Screw, 45mm
• 00849044070422: 8.5mm REVLOK HA 5.5 Screw, 40mm
• 00849044070415: 8.5mm REVLOK HA 5.5 Screw, 35mm
• 00849044070408: 8.5mm REVLOK HA 5.5 Screw, 30mm
• 00849044070392: 8.5mm REVLOK HA 5.5 Screw, 25mm
• 00849044070385: 7.5mm REVLOK HA 5.5 Screw, 90mm
• 00849044070378: 7.5mm REVLOK HA 5.5 Screw, 85mm
• 00849044070361: 7.5mm REVLOK HA 5.5 Screw, 80mm
• 00849044070354: 7.5mm REVLOK HA 5.5 Screw, 75mm
• 00849044070347: 7.5mm REVLOK HA 5.5 Screw, 70mm
• 00849044070330: 7.5mm REVLOK HA 5.5 Screw, 65mm
• 00849044070323: 7.5mm REVLOK HA 5.5 Screw, 60mm
• 00849044070316: 7.5mm REVLOK HA 5.5 Screw, 55mm
• 00849044070309: 7.5mm REVLOK HA 5.5 Screw, 50mm
• 00849044070293: 7.5mm REVLOK HA 5.5 Screw, 45mm
• 00849044070286: 7.5mm REVLOK HA 5.5 Screw, 40mm
• 00849044070279: 7.5mm REVLOK HA 5.5 Screw, 35mm
• 00849044070262: 7.5mm REVLOK HA 5.5 Screw, 30mm
• 00849044070255: 7.5mm REVLOK HA 5.5 Screw, 25mm
• 00849044070248: 6.5mm REVLOK HA 5.5 Screw, 65mm
• 00849044070231: 6.5mm REVLOK HA 5.5 Screw, 60mm
• 00849044070224: 6.5mm REVLOK HA 5.5 Screw, 55mm
• 00849044070217: 6.5mm REVLOK HA 5.5 Screw, 50mm
• 00849044070200: 6.5mm REVLOK HA 5.5 Screw, 45mm
• 00849044070194: 6.5mm REVLOK HA 5.5 Screw, 40mm
• 00849044070187: 6.5mm REVLOK HA 5.5 Screw, 35mm
• 00849044070170: 6.5mm REVLOK HA 5.5 Screw, 30mm
• 00849044070163: 6.5mm REVLOK HA 5.5 Screw, 25mm
• 00849044070156: 5.5mm REVLOK HA 5.5 Screw, 55mm
• 00849044070149: 5.5mm REVLOK HA 5.5 Screw, 50mm
• 00849044070132: 5.5mm REVLOK HA 5.5 Screw, 45mm
• 00849044070125: 5.5mm REVLOK HA 5.5 Screw, 40mm
• 00849044070118: 5.5mm REVLOK HA 5.5 Screw, 35mm
• 00849044070101: 5.5mm REVLOK HA 5.5 Screw, 30mm
• 00849044070095: 5.5mm REVLOK HA 5.5 Screw, 25mm
• 00849044070088: REVLOK 5.5 Locking Cap
• 00849044070002: 8.5mm REVLOK 5.5 Screw, 90mm
• 00849044069990: 8.5mm REVLOK 5.5 Screw, 85mm
• 00849044069983: 8.5mm REVLOK 5.5 Screw, 80mm
• 00849044069976: 8.5mm REVLOK 5.5 Screw, 75mm
• 00849044069969: 8.5mm REVLOK 5.5 Screw, 70mm