HEALIX Ti DYNATAPE 280809

GUDID 10886705031177

HEALIX Ti Anchor w/ DYNATAPE Suture HEALIX Ti Anchor (1) White/Black 2.5mm DYNATAPE Suture (1) Blue, Size 2 (5 Metric), DYNACORD Suture, 36 inch (91 cm) WHITE 6.5mm

Medos International Sàrl

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10886705031177
• NIH Device Record Key: 2577a0ad-5a10-4bd5-89a0-c79188ac7240
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALIX Ti DYNATAPE
• Version Model Number: 280809
• Catalog Number: 280809
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• 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: +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	10886705031177 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203794

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: 2021-03-12
• Device Publish Date: 2021-03-04

On-Brand Devices [HEALIX Ti DYNATAPE]

• 10886705031177: HEALIX Ti Anchor w/ DYNATAPE Suture HEALIX Ti Anchor (1) White/Black 2.5mm DYNATAPE Suture (1) B
• 10886705031160: HEALIX Ti Anchor w/ DYNATAPE Suture HEALIX Ti Anchor (1) Black/Blue 2.5mm DYNATAPE Suture (1) Wh
• 10886705031153: HEALIX Ti Anchor w/ DYNATAPE Suture HEALIX Ti Anchor (1) White/Black 2.5mm DYNATAPE Suture (1) B
• 10886705031146: HEALIX Ti Anchor w/ DYNATAPE Suture HEALIX Ti Anchor (1) Black/Blue 2.5mm DYNATAPE Suture (1) Wh
• 10886705031139: HEALIX Ti Anchor w/ DYNATAPE Suture HEALIX Ti Anchor (1) White/Black 2.5mm DYNATAPE Suture (1) B
• 10886705031122: HEALIX Ti Anchor w/ DYNATAPE Suture HEALIX Ti Anchor (1) Black/Blue 2.5mm DYNATAPE Suture (1) Wh