ULTRAFIX RC STITCHPAK 10282

GUDID 20845854040321

ULTRAFIX RC STITCHPAK, SUTURE ANCHOR WITH (2) ATTACH No. 2 (5MM) POLYESTER SUTURE

Conmed Corporation

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 20845854040321
• NIH Device Record Key: 2407c9ef-1935-4650-b14e-0282e64a1a80
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ULTRAFIX RC STITCHPAK
• Version Model Number: 10282
• Catalog Number: 10282
• 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
• 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	20845854040321 [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

Devices Manufactured by Conmed Corporation

• 30653405987585 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
• 30653405987592 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
• 30653405987608 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit, 220V-240V 50/60 Hz
• 30653405990141 - PlumeSafe® X5™: 2024-10-22 PlumeSafe® X5™ Smoke Evacuation Unit with PlumeSafe® X5™ Smoke Evacuator Filter, 220V-240V 50/60 Hz
• 20653405990120 - BioBrace: 2024-09-30 BioBrace® Reinforced Implant, 23 x 25 mm
• 20653405990137 - BioBrace: 2024-09-30 BioBrace® Reinforced Implant, 35 x 25 mm
• 20653405990144 - BioBrace: 2024-09-30 BioBrace® Reinforced Implant, 40 x 60 mm
• 20653405990151 - BioBrace: 2024-09-30 BioBrace® Reinforced Implant, Foot & Ankle, 40 x 60 mm