HEALIX ADVANCE DYNATAPE DYNACORD 280735

GUDID 10886705031016

HEALIX ADVANCE BR Anchor w/ DYNATAPE Suture TCP/PLGA Absorbable Anchor with (1) 2.5mm Black/Blue DYNATAPE Braided Flat Suture, 36inch (91 cm) and (1) White/Blue/Green, Size 2 (5 metric) DYNACORD Braided Suture, 36inch (91cm), (1) Utility Shuttle Suture 4.5mm

Medos International Sàrl

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10886705031016
• NIH Device Record Key: ac1ba9f5-2ad6-4400-8664-eb905bc2f8a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALIX ADVANCE DYNATAPE DYNACORD
• Version Model Number: 280735
• Catalog Number: 280735
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: false
• 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
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 and 77 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 25 Degrees Celsius
• Handling Environment Temperature: Between 0 and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705031016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200949

FDA Product Code

• MAI: Fastener, fixation, biodegradable, 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: 2020-10-22
• Device Publish Date: 2020-10-14

On-Brand Devices [HEALIX ADVANCE DYNATAPE DYNACORD]

• 10886705031115: HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture PEEK Anchor with (1) 2.5mm White/Black DYNATAPE Br
• 10886705031108: HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture PEEK Anchor with (1) 2.5mm Black/Blue DYNATAPE Bra
• 10886705031092: HEALIX ADVANCE BR Anchor w/ DYNATAPE Suture TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blac
• 10886705031085: HEALIX ADVANCE BR Anchor w/ DYNATAPE Suture TCP/PLGA Absorbable Anchor with (1) 2.5mm Black/Blue
• 10886705031078: HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture PEEK Anchor with (1) 2.5mm White/Black DYNATAPE Br
• 10886705031061: HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture PEEK Anchor with (1) 2.5mm Black/Blue DYNATAPE Bra
• 10886705031054: HEALIX ADVANCE BR Anchor w/ DYNATAPE Suture TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blac
• 10886705031047: HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture PEEK Anchor with (1) 2.5mm White/Black DYNATAPE Br
• 10886705031030: HEALIX ADVANCE PEEK Anchor w/ DYNATAPE Suture PEEK Anchor with (1) 2.5mm Black/Blue DYNATAPE Bra
• 10886705031023: HEALIX ADVANCE BR Anchor w/ DYNATAPE Suture TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blac
• 10886705031016: HEALIX ADVANCE BR Anchor w/ DYNATAPE Suture TCP/PLGA Absorbable Anchor with (1) 2.5mm Black/Blue
• 10886705031009: HEALIX ADVANCE BR Anchor w/ DYNATAPE Suture TCP/PLGA Absorbable Anchor with (1) 2.5mm Black/Blue