Fibula Nail ZF-HMMR

GUDID 00841731136367

Fibula, Mallet

VILEX LLC

Surgical mallet Surgical mallet Surgical mallet Surgical mallet Surgical mallet Surgical mallet Surgical mallet Surgical mallet Surgical mallet Surgical mallet Surgical mallet Surgical mallet

Primary Device ID	00841731136367
NIH Device Record Key	4b515c10-9d72-4935-803d-a49672fb92b1
Commercial Distribution Status	In Commercial Distribution
Brand Name	Fibula Nail
Version Model Number	ZF-HMMR
Catalog Number	ZF-HMMR
Company DUNS	117502293
Company Name	VILEX LLC
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	00841731136367 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151456

FDA Product Code

GFJ	Mallet, Surgical, General & Plastic Surgery