BUCK 914535

GUDID 23596010416807

BUCK CEMENT RESTRICTOR 13MM

Smith & Nephew, Inc.

Polymer orthopaedic cement restrictor, non-bioabsorbable, sterile

• Primary Device ID: 23596010416807
• NIH Device Record Key: 236f5e7c-b543-41bc-a163-5980cd7af7cd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BUCK
• Version Model Number: 914535
• Catalog Number: 914535
• 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: 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)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	03596010416803 [Primary]
GS1	23596010416807 [Package]; Contains: 03596010416803; Package: BX [3 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K791125

FDA Product Code

• LZN: CEMENT OBTURATOR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [BUCK]

• 23596010493624: 30MM BUCK CEMENT PLUG W/ DISPOSABLE INSERTER
• 23596010493617: 25MM BUCK CEMENT PLUG W/ DISPOSABLE INSERTER
• 23596010493600: 18.5MM BUCK CEMENT PLUG W/ DISPOSABLE INSERTER
• 23596010416807: BUCK CEMENT RESTRICTOR 13MM
• 23596010191087: BUCK CEMENT RESTRICTOR SIZE 35MM
• 23596010191070: BUCK CEMENT RESTRICTOR SIZE 30MM
• 23596010086444: BUCK FEMORAL CEMENT RESTRICTOR 25MM
• 23596010086437: BUCK FEMORAL CEMENT RESTRICTOR 18.5MM
• 03596010041968: BUCK FEMORAL CEMENT RESTRICTOR INSERTER