ULTRAFIX RC 10160A

GUDID 10845854037096

ULTRAFIX RC SUTURE ANCHOR, ROTATOR CUFF, 5 EA

Conmed Corporation

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 10845854037096
• NIH Device Record Key: 61ce20ea-c044-4cfe-9032-87e03fa12b0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRAFIX RC
• Version Model Number: 10160A
• Catalog Number: 10160A
• Company DUNS: 071595540
• Company Name: Conmed Corporation
• Device Count: 5
• 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
• 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
• 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

Device Dimensions

• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter
• Outer Diameter: 2.9 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845854037099 [Unit of Use]
GS1	10845854037096 [Package]; Contains: 20845854037093; Package: BOX [5 Units]; In Commercial Distribution
GS1	20845854037093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960439

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 [ULTRAFIX RC]

• 20845854040291: ULTRAFIX RC SUTURE ANCHOR, ROTATOR CUFF
• 20845854040284: ULTRAFIX RC SUTURE ANCHOR AND DISPOSABLE INSERTER
• 10845854037096: ULTRAFIX RC SUTURE ANCHOR, ROTATOR CUFF, 5 EA
• 10845854015971: ULTRAFIX RC STITCHPAK, SUTURE ANCHOR WITH ATTACHED #2 (5MM) POLYESTER SUTURE, ROTATOR CUFF, 5 EA
• 20845854015657: ULTRAFIX RC STITCHPAK , SUTURE ANCHOR WITH ATTACHED No. 2 (5MM) POLYESTER SUTURE, ROTATOR CUFF