SOFTSILK and CLEARTRAC 7205655

GUDID 03596010375094

SOFTSILK 2.0 SCR 9X20 IN CANN LTX FREE

Smith & Nephew, Inc.

Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 03596010375094
• NIH Device Record Key: b387dc46-efdd-4a59-981a-ab14c7c1a81b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SOFTSILK and CLEARTRAC
• Version Model Number: 7205655
• Catalog Number: 7205655
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)821-5700
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010375094 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972599

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-23

On-Brand Devices [SOFTSILK and CLEARTRAC]

• 03596010375117: SILK 2.0 SCR 9X30 IN CANN LTX FREE
• 03596010375100: SOFTSILK 2.0 SCR 9X25 IN CANN LTX FREE
• 03596010375094: SOFTSILK 2.0 SCR 9X20 IN CANN LTX FREE
• 03596010375087: SOFTSILK 2.0 SCR 8X30 IN CANN LTX FREE
• 03596010375070: SOFTSILK 2.0 SCR 8X25 IN CANN LTX FREE
• 03596010375063: SOFTSILK 2.0 SCR 8X20 IN CANN LTX FREE
• 03596010375056: SOFTSILK 2.0 SCR 7X30 IN CANN LTX FREE
• 03596010375049: SOFTSILK SCR 2.0 7X25 IN CANN LTX FREE
• 03596010375032: SOFTSILK 2.0 SCR 7X20 IN CANN LTX FREE
• 03596010375025: SOFTSILK 1.5 SCR 9X30 IN CANN LTX FREE (
• 03596010375018: SOFTSILK 1.5 SCR 9X25 IN CANN LTX FREE
• 03596010375001: SOFTSILK 1.5 SCR 8X30 IN CANN LTX FREE (
• 03596010374998: SOFTSILK SCR 1.5 8X25 IN CANN LTX FREE (
• 03596010374981: SOFTSILK SCR 1.5 7X30 IN CANN LTX FREE (
• 03596010374974: SOFTSILK SCR 1.5 7X25 IN CANN LTX FREE
• 03596010374967: SOFTSILK 1.5 SCR 9X20 IN CANN LTX FREE (
• 03596010374950: SOFTSILK SCR 1.5 8X20 IN CANN LTX FREE (
• 03596010374943: SOFTSILK SCR 1.5 7X20 IN CANN LTX FREE (