BIOSURE REGENESORB 72204405

GUDID 00885554036817

SCREW BIOSURE REGENESORB 9MM X 30MM

Smith & Nephew, Inc.

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 00885554036817
• NIH Device Record Key: e253f631-4d05-4c8d-8b29-4ac55ceaae26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIOSURE REGENESORB
• Version Model Number: 72204405
• Catalog Number: 72204405
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 90 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885554036817 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142948

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: 2019-03-21
• Device Publish Date: 2017-08-07

On-Brand Devices [BIOSURE REGENESORB]

• 00885554036909: SCREW BIOSURE REGENESORB 12MM X 35MM
• 00885554036893: SCREW BIOSURE REGENESORB 11MM X 35MM
• 00885554036886: SCREW BIOSURE REGENESORB 11MM X 30MM
• 00885554036879: SCREW BIOSURE REGENESORB 11MM X 25MM
• 00885554036862: SCREW BIOSURE REGENESORB 10MM X 35MM
• 00885554036855: SCREW BIOSURE REGENESORB 10MM X 30MM
• 00885554036848: SCREW BIOSURE REGENESORB 10MM X 25MM
• 00885554036831: SCREW BIOSURE REGENESORB 10MM X 20MM
• 00885554036824: SCREW BIOSURE REGENESORB 9MM X 35MM
• 00885554036817: SCREW BIOSURE REGENESORB 9MM X 30MM
• 00885554036800: SCREW BIOSURE REGENESORB 9MM X 25MM
• 00885554036794: SCREW BIOSURE REGENESORB 9MM X 20MM
• 00885554036787: SCREW BIOSURE REGENESORB 8MM X 35MM
• 00885554036770: SCREW BIOSURE REGENESORB 8MM X 30MM
• 00885554036763: SCREW BIOSURE REGENESORB 8MM X 25MM RT
• 00885554036756: SCREW BIOSURE REGENESORB 8MM X 25MM
• 00885554036749: SCREW BIOSURE REGENESORB 8MM X 20MM
• 00885554036732: SCREW BIOSURE REGENESORB 7MM X 30MM
• 00885554036725: SCREW BIOSURE REGENESORB 7MM X 25MM RT
• 00885554036718: SCREW BIOSURE REGENESORB 7MM X 25MM
• 00885554036701: SCREW BIOSURE REGENESORB 7MM X 20MM
• 00885554036695: SCREW BIOSURE REGENESORB 6MM X 25MM RT
• 00885554036688: SCREW BIOSURE REGENESORB 6MM X 25MM
• 00885554036671: SCREW BIOSURE REGENESORB 6MM X 20MM
• 00885554036664: SCREW BIOSURE REGENESORB 5MM X 25MM
• 00885554036572: BIOSURE REGEN SCREW 5 X 20MM