Trauma-Trigen E0016595-1

GUDID 00885556759820

INTERTAN DRILL GUIDE HANDLE (LA)

Smith & Nephew, Inc.

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting 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