Trauma-Int-Fix E0016668-2

GUDID 00885556772263

2.5MM PUSH SCEW SLEEVE

Smith & Nephew, Inc.

Surgical drill guide, reusable

• Primary Device ID: 00885556772263
• NIH Device Record Key: 8ad865cd-1026-4046-9b57-976549b74303
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trauma-Int-Fix
• Version Model Number: E0016668-2
• Catalog Number: E0016668-2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556772263 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162078

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

[00885556772263]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-23
• Device Publish Date: 2019-12-13

On-Brand Devices [Trauma-Int-Fix]

• 00885556772270: 2.5MM PUSH SCREW SHAFT
• 00885556772263: 2.5MM PUSH SCEW SLEEVE