HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD 222454

GUDID 10886705030842

HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm Blue PERMATAPE Braided Flat Suture, 38" (96 cm) and (1) White/Blue/Green, Size 2 (5 metric) DYNACORD Braided Suture, 36" (91cm), (1) Utility Shuttle Suture 4.5mm

Medos International Sàrl

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10886705030842
• NIH Device Record Key: 916410ca-183e-4421-b79d-cf0e311a1502
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD
• Version Model Number: 222454
• Catalog Number: 222454
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705030842 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191483

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: 2019-07-19
• Device Publish Date: 2019-07-11

On-Brand Devices [HEALIX ADVANCE DYNA+TAPE PERMATAPE DYNACORD]

• 10886705030941: HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm Blue PERMATAPE Braided
• 10886705030934: HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm White/Blue PERMATAPE B
• 10886705030927: HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm Blue PERMATAPE Braided
• 10886705030910: HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm White/Blue PERMATAPE B
• 10886705030903: HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm Blue PERMATAPE Braided
• 10886705030897: HEALIX ADVANCE PEEK Anchor w/DYNA+TAPE Sutures PEEK Anchor with (1) 2.5mm White/Blue PERMATAPE B
• 10886705030880: HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm Blue PERM
• 10886705030873: HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blu
• 10886705030866: HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm Blue PERM
• 10886705030859: HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blu
• 10886705030842: HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm Blue PERM
• 10886705030835: HEALIX ADVANCE BR Anchor w/DYNA+TAPE Sutures TCP/PLGA Absorbable Anchor with (1) 2.5mm White/Blu