Katalyst Biopolar Radial Head System 225918

GUDID 00885556827468

18MM RADIAL HEAD SIZING WAND

Smith & Nephew, Inc.

Elbow radius prosthesis

• Primary Device ID: 00885556827468
• NIH Device Record Key: f971cd30-8af7-44d1-aef0-bf23eba455e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Katalyst Biopolar Radial Head System
• Version Model Number: 225918
• Catalog Number: 225918
• Company DUNS: 045483575
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556827468 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032806

FDA Product Code

• KWI: PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Sterilization

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

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

[00885556827468]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2023-01-19

On-Brand Devices [Katalyst Biopolar Radial Head System]

• 00885556827505: KATALYST NYLON DEMO HOLDER
• 00885556827406: TRIAL - RADIAL HEAD: 24MM
• 00885556827390: TRIAL - RADIAL HEAD: 21MM
• 00885556827383: TRIAL - RADIAL HEAD: 18MM
• 00885556827376: TRIAL. STEM / SHAFT - 7.5MM
• 00885556827369: TRIAL. STEM / SHAFT - 6.5MM
• 00885556827277: KATALYST STERILIZATION TRAY
• 00885556827352: REPLACEMENT SET SCREW
• 00885556827345: 7.5MM KATALYST STEM
• 00885556827338: 6.5MM KATALYST STEM
• 00885556827321: 24MM KATALYST RADIAL HEAD
• 00885556827482: 24MM RADIAL HEAD SIZING WAND
• 00885556827475: 21MM RADIAL HEAD SIZING WAND
• 00885556827468: 18MM RADIAL HEAD SIZING WAND