Xiros n/a

GUDID 05060267133304

8mm x 23mm Fastlok

XIROS LTD

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 05060267133304
• NIH Device Record Key: 022be911-3672-421a-96bc-7d1babeaad8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Xiros
• Version Model Number: 102-1381
• Catalog Number: n/a
• Company DUNS: 228209805
• Company Name: XIROS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk
• Phone: +4401132387202
• Email: enquiries@xiros.co.uk

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060267133304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K913461

FDA Product Code

• JDR: Staple, Fixation, Bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-03
• Device Publish Date: 2023-07-26

On-Brand Devices [Xiros]

• 05060267131867: FlexPasser Tendon Retrieval Kit
• 05060267133304: 8mm x 23mm Fastlok
• 05060267133298: 6mm x 23mm Fastlok