Bio-Flek

GUDID 00763000299101

HEAD SUPPORT 1358225 BIOFLEK SURGICAL

MEDTRONIC XOMED, INC.

ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest ENT headrest

• Primary Device ID: 00763000299101
• NIH Device Record Key: 755a61ed-22dc-456b-ada5-c4d195bd4f41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bio-Flek
• Version Model Number: 1358225
• Company DUNS: 835465063
• Company Name: MEDTRONIC XOMED, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000299101 [Primary]

FDA Product Code

• EPW: Support, head, surgical, ENT

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-03
• Device Publish Date: 2021-04-25

On-Brand Devices [Bio-Flek]

• 00763000299118: HEAD SUPPORT 1358227 BIOFLEK RISER
• 00763000299101: HEAD SUPPORT 1358225 BIOFLEK SURGICAL
• 00681490039024: HEAD SUPPORT 1358227 BIOFLEK RISER
• 00681490039017: HEAD SUPPORT 1358225 BIOFLEK SURGICAL