Large Cannulated Screw System E0015583-4

GUDID 00885556695906

LARGE CANNULATED SCREW MEASURING GAUGE

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit 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