74033638

GUDID 00885556532997

UNIVERSAL INSERT SPACER SZ3-4 25MM

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00885556532997
• NIH Device Record Key: 1b0a487f-b7d6-43d7-b6aa-126f97e10655
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 74033638
• Catalog Number: 74033638
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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
• 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	00885556532997 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111711

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Sterilization

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

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

[00885556532997]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2015-08-30

Devices Manufactured by Smith & Nephew, Inc.

• 00885556893708 - TRIGEN MAX: 2025-05-14 TRIGEN MAX TIBIA NAIL 11MM X 25CM LEFT
• 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