HEALIX TRANSTEND 271064

GUDID 10886705033195

HEALIX TRANSTENDTM PEEK Anchor_x000D_ w/ Dual Strand 1.3mm PERMATAPE

Medos International Sàrl

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10886705033195
• NIH Device Record Key: d10fdacb-2847-4608-987b-5498f61439d1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALIX TRANSTEND
• Version Model Number: 271064
• Catalog Number: 271064
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705033195 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243790

FDA Product Code

• MBI: Fastener, fixation, nondegradable, soft tissue

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: 2025-04-30
• Device Publish Date: 2025-04-22

On-Brand Devices [HEALIX TRANSTEND]

• 10886705033256: HEALIX TRANSTEND X TAP REUSABLE
• 10886705033195: HEALIX TRANSTENDTM PEEK Anchor_x000D_ w/ Dual Strand 1.3mm PERMATAPE
• 10886705033188: HEALIX TRANSTENDTM PEEK Anchor w/ 1.3mm PERMATAPE™