HEALIX PEEK ORTHOCORD 222205

GUDID 10886705007530

HEALIX PEEK Anchor w/ORTHOCORD PEEK Anchor (1) Violet (1) Blue strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) 4.5mm

Medos International Sàrl

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10886705007530
• NIH Device Record Key: fe7684cc-51b1-4b29-bc7f-4f42c622572b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HEALIX PEEK ORTHOCORD
• Version Model Number: 222205
• Catalog Number: 222205
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• 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
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• Phone: +1(800)255-2500
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• 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
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
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• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
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• 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 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
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• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
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• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
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• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705007530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071481

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2023-12-22
• Device Publish Date: 2015-09-01

On-Brand Devices [HEALIX PEEK ORTHOCORD]

• 10886705023837: HEALIX PEEK Anchor (1) PEEK Anchor (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided compos
• 10886705007691: HEALIX PEEK Anchor w/ORTHOCORD PEEK Anchor (1) Violet, (1) Blue strand, Size 2 (5 metric) ORTHOC
• 10886705007677: HEALIX PEEK 3 - Suture Anchor w/ORTHOCORD PEEK Anchor (1) Violet, (1) Blue Strand, (1) Blue Stri
• 10886705007639: HEALIX PEEK Anchor w/ORTHOCORD and Needles PEEK Anchor (1) Violet, (1) Blue strand, Size 2 (5 me
• 10886705007585: HEALIX PEEK Anchor w/ORTHOCORD and Needles PEEK Anchor (1) Violet, (1) Blue strand, Size 2 (5 me
• 10886705007578: HEALIX PEEK Anchor w/ORTHOCORD PEEK Anchor (1) Violet, (1) Blue strand, Size 2 (5 metric) ORTHOC
• 10886705007554: HEALIX PEEK 3 - Suture Anchor w/ORTHOCORD PEEK Anchor (1) Violet, (1) Blue Strand, (1) Blue Stri
• 10886705007530: HEALIX PEEK Anchor w/ORTHOCORD PEEK Anchor (1) Violet (1) Blue strand, Size 2 (5 metric) ORTHOCO