Katalyst Bipolar Radial Head System 226000

GUDID 00885556827499

STARTER AWL

Smith & Nephew, Inc.

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• Primary Device ID: 00885556827499
• NIH Device Record Key: b9c0f28b-9526-4525-8ef2-bab01839c365
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Katalyst Bipolar Radial Head System
• Version Model Number: 226000
• Catalog Number: 226000
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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
• 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	00885556827499 [Primary]

FDA Product Code

• HWJ: AWL

Sterilization

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

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

[00885556827499]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-09
• Device Publish Date: 2023-02-01

On-Brand Devices [Katalyst Bipolar Radial Head System]

• 00885556827536: FIRST SPACER
• 00885556827529: SPACERS 2MM. WRENCH
• 00885556827512: KATALYST ASSEMBLY PLIERS
• 00885556827499: STARTER AWL
• 00885556827451: HEAD SIZING FIXTURE
• 00885556827444: CUTTING TEMPLATE
• 00885556827437: BROACH. 7.5MM X 20MM
• 00885556827420: BROACH 6.5MM X 20MM
• 00885556827291: SIZING WAND INSTRUMENT CASE
• 00885556827284: SIZING WAND CASE LID
• 00885556834909: HEX DRIVER. 2.5MM
• 00885556827314: 21MM KATALYST RADIAL HEAD
• 00885556827307: 18MM KATALYST RADIAL HEAD