XO BUTTON T5055

GUDID 20845854015817

55MM XO BUTTON WITH CONTINUOUS LOOP

Conmed Corporation

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 20845854015817
• NIH Device Record Key: 0784cfc5-7aff-405f-b7a8-3bedffa45066
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XO BUTTON
• Version Model Number: T5055
• Catalog Number: T5055
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• 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)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 42 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM UV LIGHT
• Storage Environment Temperature: Between 0 Degrees Celsius and 42 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM UV LIGHT
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM UV LIGHT
• Storage Environment Temperature: Between 0 and 42 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM UV LIGHT
• Storage Environment Temperature: Between 0 and 42 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM UV LIGHT
• Storage Environment Temperature: Between 0 and 42 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM UV LIGHT
• Storage Environment Temperature: Between 0 and 42 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *KEEP AWAY FROM UV LIGHT
• Storage Environment Temperature: Between 0 and 42 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	20845854015817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070780

FDA Product Code

• MBI: FASTENER, FIXATION, NONDEGRADABLE, 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: 2019-03-21
• Device Publish Date: 2015-10-24

On-Brand Devices [XO BUTTON]

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• 20845854015947: 25MM XO BUTTON WITH CONTINUOUS LOOP
• 20845854015817: 55MM XO BUTTON WITH CONTINUOUS LOOP
• 20845854015633: 40MM XO BUTTON WITH CONTINUOUS LOOP
• 20845854015626: 35MM XO BUTTON WITH CONTINUOUS LOOP
• 20845854015619: 50MM XO BUTTON WITH CONTINUOUS LOOP
• 20845854012663: 20MM XO BUTTON WITH CONTINUOUS LOOP
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