Vilex Drill

GUDID 00841731119650

Drill, 3.5mm Solid QC, 195/50mm flute (AVID)

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	00841731119650
NIH Device Record Key	ccabafad-4bb0-4f5b-8bef-c6b90cd49b31
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vilex Drill
Version Model Number	DA3550
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	00841731119650 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K041287

FDA Product Code

HRS	Plate, Fixation, Bone