HEALIX TI ANCHOR w/DYNACORD 222054

GUDID 10886705029938

HEALIX TI ANCHOR w/DYNACORD Titanium Anchor (1) Blue (1) White/Blue/Green Striped, Size 2 (5 Metric), DYNACORD Suture, 36" (91 cm) 5.5mm

Medos International Sàrl

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10886705029938
• NIH Device Record Key: 9044f475-354a-4901-b50a-e063c486ca32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALIX TI ANCHOR w/DYNACORD
• Version Model Number: 222054
• Catalog Number: 222054
• 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
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705029938 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K183279

FDA Product Code

• HWC: Screw, 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: 2020-10-02
• Device Publish Date: 2020-09-24

On-Brand Devices [HEALIX TI ANCHOR w/DYNACORD]

• 10886705029976: HEALIX TI ANCHOR w/DYNACORD AND NEEDLES Titanium Anchor (1) Blue (1) White/Blue/Green Striped, S
• 10886705029969: HEALIX TI ANCHOR w/DYNACORD Titanium Anchor (1) Blue (1) White/Blue/Green Striped, Size 2 (5 Met
• 10886705029945: HEALIX TI ANCHOR w/DYNACORD AND NEEDLES Titanium Anchor (1) Blue (1) White/Blue/Green Striped, S
• 10886705029938: HEALIX TI ANCHOR w/DYNACORD Titanium Anchor (1) Blue (1) White/Blue/Green Striped, Size 2 (5 Met