Endo-Misc E0016416-2

GUDID 00885556741696

3.4MM HEX DRIVER

Smith & Nephew, Inc.

Orthopaedic implant driver

• Primary Device ID: 00885556741696
• NIH Device Record Key: bcca80d6-87de-4e23-b411-285e2349fbce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endo-Misc
• Version Model Number: E0016416-2
• Catalog Number: E0016416-2
• 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
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556741696 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921481

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

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

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

[00885556741696]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-29
• Device Publish Date: 2019-03-21

On-Brand Devices [Endo-Misc]

• 00885556741696: 3.4MM HEX DRIVER
• 00885556741689: 2.7MM HEX DRIVER
• 00885556715154: EXTENDED HIP GRASPER
• 00885556706428: EXTENDED HIP GRASPER