74035903

GUDID 00885556691007

RIGHT MEDIAL TIBIA INTERACTIVE SIZING TRIAL SZ 5-6

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00885556691007
• NIH Device Record Key: b6e8da1a-313f-4edb-bf6a-e090985a0420
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 74035903
• Catalog Number: 74035903
• 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
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• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556691007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190085

FDA Product Code

• HSX: PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

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

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

[00885556691007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-24
• Device Publish Date: 2019-06-14

Devices Manufactured by Smith & Nephew, Inc.

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• 00885556915882 - DIRECT VIEW AND VIDEO SCOPE: 2025-07-01 4KO VIDEOARTHROSCOPE AC 4 X 70 DEG X 160MM REVERSE POST
• 00885556915899 - DIRECT VIEW AND VIDEO SCOPES: 2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4X 30 DEG X 160MM REVERSE POST
• 00885556915905 - DIRECT VIEW AND VIDEO SCOPE: 2025-07-01 SERVICE REPLACEMENT 4KO VAS AC 4 X 70 DEG X 160MM RND TIP REV POST
• 00885556900284 - TRIGEN MAX: 2025-06-10 TRIGEN MAX 13MM WASHER
• 00885556901960 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 26MM CORTEX SCREW BLUNT TIP
• 00885556901977 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 28MM CORTEX SCREW BLUNT TIP
• 00885556901984 - EVOS: 2025-06-02 EVOS PELVIC 2.7MM X 30MM CORTEX SCREW BLUNT TIP