OTHER EXFIX 122718

GUDID 03596010069528

TITANIUM HALF PIN 5.0MM X 75MM

Smith & Nephew, Inc.

External orthopaedic fixation system, single-use

• Primary Device ID: 03596010069528
• NIH Device Record Key: be64b313-b5a1-4b7a-be46-0ad1fce29842
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OTHER EXFIX
• Version Model Number: 122718
• Catalog Number: 122718
• 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: 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
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010069528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201253
• Premarket Notification: K920024

FDA Product Code

• KTT: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

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

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

[03596010069528]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-11-23
• Device Publish Date: 2015-09-28

On-Brand Devices [OTHER EXFIX]

• 03596010171030: STAINLESS STEEL HALF PIN 6MM X 55MM
• 03596010170941: TITANIUM HALF PIN 6MM X 55MM
• 03596010170934: TITANIUM HALF PIN 6MM X 45MM
• 03596010069610: TITANIUM HALF PIN 6.0MM X 90MM
• 03596010069528: TITANIUM HALF PIN 5.0MM X 75MM
• 03596010069511: TITANIUM HALF PIN 5.0MM X 70MM
• 03596010069405: TITANIUM HALF PIN 4.0MM X 50MM
• 03596010069399: TITANIUM HALF PIN 4.0MM X 45MM