Solid ePTFE Paranasal, Flat Top ES-PF-50

GUDID M724ESPF501

Malar prosthesis

Primary Device ID	M724ESPF501
NIH Device Record Key	458a5e86-a62f-49e0-ae91-2ff7afd2cc08
Commercial Distribution Status	In Commercial Distribution
Brand Name	Solid ePTFE Paranasal, Flat Top
Version Model Number	size:5mm
Catalog Number	ES-PF-50
Company DUNS	784664955
Company Name	IMPLANTECH ASSOCIATES, 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	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	M724ESPF501 [Primary]

LZK	Implant, Malar

Steralize Prior To Use	false
Device Is Sterile	true

M724ESPF701	Solid ePTFE Paranasal, Flat Top
M724ESPF501	Solid ePTFE Paranasal, Flat Top