Trauma-Trigen E0016595-1

GUDID 00885556759820

INTERTAN DRILL GUIDE HANDLE (LA)

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00885556759820
• NIH Device Record Key: 21049aac-da5c-46b9-befc-af0a42bb8b35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trauma-Trigen
• Version Model Number: E0016595-1
• Catalog Number: E0016595-1
• 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	00885556759820 [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

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

[00885556759820]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-22
• Device Publish Date: 2019-08-14

On-Brand Devices [Trauma-Trigen]

• 00885556759820: INTERTAN DRILL GUIDE HANDLE (LA)
• 00885556790250: FLEXIBLE REAMER SHAFT / HEAD 12.5MM
• 00885556791509: 15MM REAMER HEAD
• 00885556791493: 14.5MM REAMER HEAD
• 00885556791486: 14MM REAMER HEAD
• 00885556791479: 13.5MM REAMER HEAD
• 00885556791370: 9MM REAMER HEAD
• 00885556791547: 10MM REAMER HEAD
• 00885556791523: 16MM REAMER HEAD
• 00885556791516: 15.5MM REAMER HEAD
• 00885556791462: 13MM REAMER HEAD
• 00885556791455: 12.5MM REAMER HEAD
• 00885556791448: 12MM REAMER HEAD
• 00885556791431: 11.5MM REAMER HEAD
• 00885556791424: 11MM REAMER HEAD
• 00885556791417: 10.5MM REAMER HEAD
• 00885556791394: 10MM REAMER HEAD
• 00885556791387: 9.5MM REAMER HEAD