Vilex Implant Accessory

GUDID 00841731114815

Washer, 4.5mm SS Screw 328x.218x.040

VILEX IN TENNESSEE, INC.

Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Orthopaedic bone washer, non-sterile Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer Implantable bone washer

Primary Device ID	00841731114815
NIH Device Record Key	9246e080-f34e-4069-876a-add5cbff398f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Vilex Implant Accessory
Version Model Number	635-45S
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	00841731114815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K991151

FDA Product Code

HWC	Screw, Fixation, Bone