ePTFE Sheet EPTFE-SHEET-083

GUDID M724EPTFESHEET0831

PTFE/carbon-fibre craniofacial tissue reconstructive material

Primary Device ID	M724EPTFESHEET0831
NIH Device Record Key	5d507267-fbba-4c1f-9aad-edf566769616
Commercial Distribution Status	In Commercial Distribution
Brand Name	ePTFE Sheet
Version Model Number	Size: 9cm x 6cm x 8mm
Catalog Number	EPTFE-SHEET-083
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	M724EPTFESHEET0831 [Primary]

FTL	Mesh, Surgical, Polymeric

Steralize Prior To Use	false
Device Is Sterile	true