Vilex Drill Cannulated

GUDID 00841731114617

Drill, FUZE 2.5x275mm QC

VILEX IN TENNESSEE, INC.

Fluted surgical drill bit, single-use, non-sterile Fluted surgical drill bit, single-use, non-sterile Fluted surgical drill bit, single-use, non-sterile Fluted surgical drill bit, single-use, non-sterile Fluted surgical drill bit, single-use, non-sterile Fluted surgical drill bit, single-use, non-sterile Fluted surgical drill bit, single-use, non-sterile

Primary Device ID	00841731114617
NIH Device Record Key	a07b7dea-ad26-48d2-add3-c9b66aec0b6b
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vilex Drill Cannulated
Version Model Number	Z402-80-25
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	true
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	00841731114617 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K102413

FDA Product Code

HSB	Rod, Fixation, Intramedullary And Accessories