BIOKNOTLESS ORTHOCORD ETHIBOND 212726

GUDID 10886705002122

BIOKNOTLESS Plus Anchor w/ORTHOCORD PLA Absorbable Anchor, Size 2 (5 metric) ORTHOCORD Braided Composite suture anchor loop, Size 2/0 green ETHIBOND braided polyester suture utility loop.

Medos International Sàrl

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10886705002122
• NIH Device Record Key: ffbcf6fe-90e8-4cd7-9a84-6213d813c4fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOKNOTLESS ORTHOCORD ETHIBOND
• Version Model Number: 212726
• Catalog Number: 212726
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
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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
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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
• 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
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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

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage 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
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705002122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062170

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-01-09
• Device Publish Date: 2015-09-01

On-Brand Devices [BIOKNOTLESS ORTHOCORD ETHIBOND]

• 10886705002122: BIOKNOTLESS Plus Anchor w/ORTHOCORD PLA Absorbable Anchor, Size 2 (5 metric) ORTHOCORD Braided C
• 10886705002085: BIOKNOTLESS BR Anchor w/ORTHOCORD TCP/PLGA Absorbable Anchor, size 2 (5 metric) ORTHOCORD braide