ePTFE Sheet EPTFE-SHEET-040

GUDID M724EPTFESHEET0401

ePTFE Sheet

IMPLANTECH ASSOCIATES, INC.

PTFE/carbon-fibre craniofacial tissue reconstructive material
Primary Device IDM724EPTFESHEET0401
NIH Device Record Keyb454dbc9-596f-4227-ad9a-e9044f14eea6
Commercial Distribution StatusIn Commercial Distribution
Brand NameePTFE Sheet
Version Model NumberSize: 10cm x 3cm x 4mm
Catalog NumberEPTFE-SHEET-040
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
HIBCCM724EPTFESHEET0401 [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

On-Brand Devices [ePTFE Sheet]

M724EPTFESHEET0611ePTFE Sheet
M724EPTFESHEET0601ePTFE Sheet
M724EPTFESHEET0409061ePTFE Sheet
M724EPTFESHEET0231ePTFE Sheet
M724EPTFESHEET0201ePTFE Sheet
M724EPTFESHEET0121ePTFE Sheet
M724EPTFESHEET0111ePTFE Sheet
M724EPTFESHEET0411ePTFE Sheet
M724EPTFESHEET0401ePTFE Sheet
M724EPTFESHEET0221ePTFE Sheet
M724EPTFESHEET0211ePTFE Sheet
M724EPTFESHEET0131ePTFE Sheet
M724EPTFESHEET0101ePTFE Sheet
M724EPTFESHEET1011ePTFE Sheet
M724EPTFESHEET0831ePTFE Sheet
M724EPTFESHEET0631ePTFE Sheet
M724EPTFESHEET055B1ePTFE Sheet
M724EPTFESHEET045B1ePTFE Sheet

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.