3134214

GUDID 00885554001082

MTO TAPERED DRIVER 3.5MM HEX NON-CANN

Smith & Nephew, Inc.

Surgical screwdriver, reusable

• Primary Device ID: 00885554001082
• NIH Device Record Key: bc4b1e47-d62c-4596-87ad-83d945f2dcfd
• Commercial Distribution Discontinuation: 2017-04-03
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: 3134214
• Catalog Number: 3134214
• 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
• 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	00885554001082 [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

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

Moist Heat or Steam Sterilization

[00885554001082]

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: 2015-08-30

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• 00885556891742 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED HIGH OFFSET SIZE 5
• 00885556891759 - CATALYSTEM: 2024-08-15 CATALYSTEM COLLARED STEM HIGH OFFSET SIZE 6
• 00885556892107 - CATALYSTEM: 2024-08-07 CATALYSTEM BROACH SIZE 0
• 00885556892114 - CATALYSTEM: 2024-08-07 CATALYSTEM BROACH SIZE 1