n/a n/a

GUDID 05060267130563

AchilloCordPLUS Poly-Tape

XIROS LTD

Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament Polyester suture, non-bioabsorbable, multifilament

• Primary Device ID: 05060267130563
• NIH Device Record Key: d755a85f-fcc2-4d53-b8ae-313e12064ac2
• Commercial Distribution Discontinuation: 2018-11-16
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: n/a
• Version Model Number: 102-1144
• Catalog Number: n/a
• Company DUNS: 228209805
• Company Name: XIROS LTD
• 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: +4401132387202
• Email: enquiries@neoligaments.com
• Phone: +4401132387202
• Email: enquiries@neoligaments.com
• Phone: +4401132387202
• Email: enquiries@neoligaments.com
• Phone: +4401132387202
• Email: enquiries@neoligaments.com
• Phone: +4401132387202
• Email: enquiries@neoligaments.com
• Phone: +4401132387202
• Email: enquiries@neoligaments.com
• Phone: +4401132387202
• Email: enquiries@neoligaments.com
• Phone: +4401132387202
• Email: enquiries@neoligaments.com
• Phone: +4401132387202
• Email: enquiries@neoligaments.com
• Phone: +4401132387202
• Email: enquiries@neoligaments.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060267130563 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002172

FDA Product Code

• GAT: Suture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-10-09

On-Brand Devices [n/a]

• 05060267131515: SECURE-LOOP 60MM
• 05060267131508: SECURE-LOOP 55MM
• 05060267131492: SECURE-LOOP 50MM
• 05060267131485: SECURE-LOOP 45MM
• 05060267131478: SECURE-LOOP 40MM
• 05060267131461: SECURE-LOOP 35MM
• 05060267131454: SECURE-LOOP 30MM
• 05060267131447: SECURE-LOOP 25MM
• 05060267131430: SECURE-LOOP 20MM
• 05060267131423: SECURE-LOOP 15MM
• 05060267131416: SECURE-LOOP 10MM
• 05060267130884: Sliding Hammer
• 05060267130785: Impactor Assembly
• 05060267130563: AchilloCordPLUS Poly-Tape
• 05060267130112: 8mm x 23mm Fastlok
• 05060267130099: 6mm x 23mm Fastlok
• 05060267131836: Infinity-Lock Button System
• 05060267131362: CC-Hook Right
• 05060267131355: CC-Hook Left