Trauma E0015724-1

GUDID 00885556704929

K-WIRE GUIDE WITH LOOP

Smith & Nephew, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00885556704929
• NIH Device Record Key: 84d236dc-457d-4c62-9425-6b17b1fd2551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trauma
• Version Model Number: E0015724-1
• Catalog Number: E0015724-1
• 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	00885556704929 [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

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

Moist Heat or Steam Sterilization

[00885556704929]

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: 2017-10-24

On-Brand Devices [Trauma]

• 00885556704929: K-WIRE GUIDE WITH LOOP
• 00885556692738: MODIFIED CONQUEST FN PROXIMAL SCREWDRIVER
• 00885556684801: LONG T8 DRIVER WITH AO QUICK CONNECT
• 00885556684795: LONG T7 DRIVER WITH AO QUICK CONNECT
• 00885556684788: LONG T6 DRIVER WITH AO QUICK CONNECT
• 00885556683606: MODIFIED 22MM CONE REAMER
• 00885556683590: MODIFIED 20MM CONE REAMER
• 00885556683583: MODIFIED 18MM CONE REAMER
• 00885556683576: MODIFIED 16MM CONE REAMER
• 00885556683569: MODIFIED 14MM CONE REAMER
• 00885556683361: MODIFIED 22MM CONE REAMER
• 00885556683354: MODIFIED 20MM CONE REAMER
• 00885556683347: MODIFIED 18MM CONE REAMER
• 00885556683330: MODIFIED 16MM CONE REAMER
• 00885556683323: MODIFIED 14MM CONE REAMER
• 00885556804322: CANNULATED DEPTH GAUGE
• 00885556804834: 205MM FORCEPS W/BALL TIP
• 00885556892480: DIRECT MEASURING GUIDE PIN SLEEVE