HEALIX ADVANCE 222426

GUDID 10886705030620

HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR TCP/PLLA Absorbable Anchor 6.5mm

Medos International Sàrl

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10886705030620
• NIH Device Record Key: 0d8c5653-27d6-40ce-88c2-46d13234eed9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALIX ADVANCE
• Version Model Number: 222426
• Catalog Number: 222426
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705030620 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201883

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: 2020-09-11
• Device Publish Date: 2020-09-03

On-Brand Devices [HEALIX ADVANCE]

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• 10886705030347: HEALIX ADVANCE KNOTLESS PEEK ANCHOR PEEK Anchor 5.5mm
• 10886705030330: HEALIX ADVANCE KNOTLESS PEEK ANCHOR PEEK Anchor 4.75mm
• 10886705030590: HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR TCP/PLLA Absorbable Anchor 5.5mm
• 10886705030576: HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR TCP/PLLA Absorbable Anchor 4.9mm
• 10886705030620: HEALIX ADVANCE SP BIOCOMPOSITE ANCHOR TCP/PLLA Absorbable Anchor 6.5mm
• 10886705030613: HEALIX ADVANCE SP PEEK ANCHOR 6.5mm
• 10886705027781: HEALIX ADVANCE ANCHOR OPEN HARD BONE KIT Open Instrumentation Kit for 4.5mm and 4.75 HEALIX ADVA