74035915

GUDID 00885556691052

LEFT MEDIAL TIBIA INTERACTIVE SIZING TRIAL SZ 7-8

Smith & Nephew, Inc.

Knee tibia prosthesis trial

• Primary Device ID: 00885556691052
• NIH Device Record Key: f2f3f4dd-a777-478f-b6c6-094ae33c2eed
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 74035915
• Catalog Number: 74035915
• 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
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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
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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
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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
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
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• Phone: +1(800)238-7538
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• Email: GUDID@SMITH-NEPHEW.COM
• 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
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• Phone: +1(800)238-7538
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Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556691052 [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

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

Moist Heat or Steam Sterilization

[00885556691052]

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.

• 00885556414965 - REFLECTION: 2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
• 00885556533574 - REFLECTION: 2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 0 DEGREE 66-68MM OUTER DIAMETER SIZE J ETO
• 00885556533581 - REFLECTION: 2025-12-11 REFLECTION XLPE 36MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
• 00885556535059 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE ANTEVERTED +4MM 50-52MM OUTER DIAMETER E ETO
• 00885556535073 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 50-52MM OUTER DIAMETER SIZE E ETO
• 00885556535080 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 54-56MM OUTER DIAMETER SIZE F ETO
• 00885556535097 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 58-60MM OUTER DIAMETERSIZE G ETO
• 00885556535103 - REFLECTION: 2025-12-11 REFLECTION XLPE 32MM INNER DIAMETER 20 DEGREE 62-64MM OUTER DIAMETER SIZE H ETO