110107

GUDID 23596010033912

SET SCREWS FOR RICHARDS COLLES FRACTURE FRAME

Smith & Nephew, Inc.

External orthopaedic fixation system, reusable

• Primary Device ID: 23596010033912
• NIH Device Record Key: adc0eb2d-ebcb-4d57-b814-cb589846fb02
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 110107
• Catalog Number: 110107
• Company DUNS: 109903521
• Company Name: Smith & Nephew, Inc.
• Device Count: 1
• DM Exempt: true
• 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
• 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
• 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	03596010033918 [Primary]
GS1	23596010033912 [Package]; Contains: 03596010033918; Package: BX [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201253
• Premarket Notification: K994143

FDA Product Code

• JDW: PIN, FIXATION, THREADED

Sterilization

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

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

[23596010033912]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-11-03
• Device Publish Date: 2015-08-29

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• 00885556897119 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 10MM X 24CM X 125D RIGHT
• 00885556897126 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 11.5MM X 24CM X 125D LEFT
• 00885556897133 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 11.5MM X 24CM X 125D RIGHT
• 00885556897201 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 9MM X 38CM X 125D LEFT
• 00885556897218 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 9MM X 40CM X 125D LEFT
• 00885556897225 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 9MM X 42CM X 125D LEFT
• 00885556897232 - INTERTAN MAX: 2025-11-19 INTERTAN MAX 9MM X 44CM X 125D LEFT