75100876

GUDID 07611996122091

TRIAL FEMORAL HEAD 44 L/+8

Smith & Nephew, Inc.

Femoral head prosthesis trial

• Primary Device ID: 07611996122091
• NIH Device Record Key: 9702c20e-f43e-4ded-9ea8-5796dd479e6b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 75100876
• Catalog Number: 75100876
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611996122091 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132435

FDA Product Code

• LZO: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Sterilization

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

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

[07611996122091]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

Devices Manufactured by Smith & Nephew, Inc.

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• 00885556891612 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 5
• 00885556891629 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED STEM STANDARD OFFSET SIZE 6
• 00885556891735 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 4
• 00885556891742 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED HIGH OFFSET SIZE 5
• 00885556891759 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 6
• 00885556892107 - CATALYSTEM: 2024-08-07 CATALYSTEM BROACH SIZE 0
• 00885556892114 - CATALYSTEM: 2024-08-07 CATALYSTEM BROACH SIZE 1