Large Cannulated Screw System E0015583-4

GUDID 00885556695906

LARGE CANNULATED SCREW MEASURING GAUGE

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00885556695906
• NIH Device Record Key: ce423229-99a9-45a6-8437-d3baa624e966
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Large Cannulated Screw System
• Version Model Number: E0015583-4
• Catalog Number: E0015583-4
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556695906 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123055

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

[00885556695906]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-08-30

On-Brand Devices [Large Cannulated Screw System]

• 00885556701850: 3.2MM X 800MM THREADED TIP GUIDE PIN
• 00885556695906: LARGE CANNULATED SCREW MEASURING GAUGE