72915001

GUDID 00885556898994

TRIGEN MAX 20MM SPIKED WASHER

Smith & Nephew, Inc.

Orthopaedic bone screw (non-sliding)

• Primary Device ID: 00885556898994
• NIH Device Record Key: 5761eec1-c37b-4eb5-a3af-f93817550f36
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 72915001
• Catalog Number: 72915001
• Company DUNS: 045483575
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -
• Special Storage Condition, Specify: Between 0 and 0 *: -

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556898994 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240061

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-13
• Device Publish Date: 2025-05-05

Devices Manufactured by Smith & Nephew, Inc.

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• 00885556893715 - TRIGEN MAX: 2025-05-14 TRIGEN MAX TIBIA NAIL 11MM X 26CM LEFT
• 00885556893722 - TRIGEN MAX: 2025-05-14 TRIGEN MAX TIBIA NAIL 11MM X 27CM LEFT
• 00885556893739 - TRIGEN MAX: 2025-05-14 TRIGEN MAX TIBIA NAIL 11MM X 28CM LEFT
• 00885556893746 - TRIGEN MAX: 2025-05-14 TRIGEN MAX TIBIA NAIL 11MM X 29CM LEFT
• 00885556893753 - TRIGEN MAX: 2025-05-14 TRIGEN MAX TIBIA NAIL 11MM X 30CM LEFT
• 00885556893760 - TRIGEN MAX: 2025-05-14 TRIGEN MAX TIBIA NAIL 11MM X 31CM LEFT
• 00885556893777 - TRIGEN MAX: 2025-05-14 TRIGEN MAX TIBIA NAIL 11MM X 32CM LEFT