Sureshot E0015644-1

GUDID 00885556704660

LONG SURESHOT HEXDRIVER

Smith & Nephew, Inc.

Surgical screwdriver, reusable

• Primary Device ID: 00885556704660
• NIH Device Record Key: b54257b9-488b-4f83-bcef-e5b2bb5c6a29
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sureshot
• Version Model Number: E0015644-1
• Catalog Number: E0015644-1
• 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	00885556704660 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122170

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

[00885556704660]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-10-05
• Device Publish Date: 2017-10-17

On-Brand Devices [Sureshot]

• 00885556704660: LONG SURESHOT HEXDRIVER
• 00885556584682: TRIGEN SURESHOT TARGETER TRAY INSERT - 2ND GENERATION
• 00885556584675: TRAUMA INTERFACE CASE - 2ND GENERATION
• 00885556584620: SURESHOT TARGETER - 2ND GENERATION