ePTFE Sheet EPTFE-SHEET-012

GUDID M724EPTFESHEET0121

ePTFE Sheet

IMPLANTECH ASSOCIATES, INC.

PTFE/carbon-fibre craniofacial tissue reconstructive material
Primary Device IDM724EPTFESHEET0121
NIH Device Record Key0773c500-f902-4c48-b576-07e23a759609
Commercial Distribution StatusIn Commercial Distribution
Brand NameePTFE Sheet
Version Model NumberSize: 9cm x 6cm x 1mm
Catalog NumberEPTFE-SHEET-012
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
HIBCCM724EPTFESHEET0121 [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 Date2019-11-14
Device Publish Date2015-09-24

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