ePTFE Paranasal ESPN-S6

GUDID M724ESPNS61

Paranasal Implant

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis
Primary Device IDM724ESPNS61
NIH Device Record Key3c4584e8-c700-4ca3-8703-94c0f2f2d425
Commercial Distribution StatusIn Commercial Distribution
Brand NameePTFE Paranasal
Version Model NumberSize: Small / 6mm
Catalog NumberESPN-S6
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
HIBCCM724ESPNS61 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZKImplant, Malar

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-11-15
Device Publish Date2019-06-14

On-Brand Devices [ePTFE Paranasal ]

M724ESPNS61Paranasal Implant
M724ESPNS51Paranasal Implant
M724ESPNM61Paranasal Implant
M724ESPNM51Paranasal Implant
M724ESPNL61Paranasal Implant
M724ESPNL51Paranasal Implant

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