Vilex Fibula Tool ZF-T10

GUDID 00841731122032

Driver, Fibula T10 Long

VILEX IN TENNESSEE, INC.

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

Primary Device ID	00841731122032
NIH Device Record Key	8527b6f9-6702-418f-b789-5172f07e5acd
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vilex Fibula Tool
Version Model Number	ZF-T10
Catalog Number	ZF-T10
Company DUNS	152008371
Company Name	VILEX IN TENNESSEE, 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841731122032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151456

FDA Product Code

HSB	Rod, Fixation, Intramedullary And Accessories