Trauma-TC-100 E0016788-1

GUDID 00885556771716

CANNULATED DEPTH GAUGE

Smith & Nephew, Inc.

Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable Surgical depth gauge, reusable

• Primary Device ID: 00885556771716
• NIH Device Record Key: add9ffc6-b12e-4e33-a00f-84a159492f37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trauma-TC-100
• Version Model Number: E0016788-1
• Catalog Number: E0016788-1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556771716 [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

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

[00885556771716]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-04
• Device Publish Date: 2019-11-26

On-Brand Devices [Trauma-TC-100]

• 00885556754894: CANNULATED DEPTH GAUGE
• 00885556771716: CANNULATED DEPTH GAUGE