ePTFE Sheet EPTFE-SHEET-010

GUDID M724EPTFESHEET0101

ePTFE Sheet

IMPLANTECH ASSOCIATES, INC.

PTFE/carbon-fibre craniofacial tissue reconstructive material
Primary Device IDM724EPTFESHEET0101
NIH Device Record Key3c3d4376-aaca-4d0f-9731-d18b444fad05
Commercial Distribution StatusIn Commercial Distribution
Brand NameePTFE Sheet
Version Model NumberSize: 8cm x 5cm x 1mm
Catalog NumberEPTFE-SHEET-010
Company DUNS784664955
Company NameIMPLANTECH ASSOCIATES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-733-0833
Emailinfo@implantech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724EPTFESHEET0101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTLMesh, Surgical, Polymeric

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-15
Device Publish Date2015-09-24

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