SU-POR Surgical Imnplant 4037

GUDID 00815285020366

Quadro-Port Tunnel Orbital Sphere 18mm

PORIFEROUS, LLC

Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material Polyethylene craniofacial tissue reconstructive material
Primary Device ID00815285020366
NIH Device Record Keye7377f2a-5c64-4c4e-aac6-427678c9ed68
Commercial Distribution StatusIn Commercial Distribution
Brand NameSU-POR Surgical Imnplant
Version Model Number4037
Catalog Number4037
Company DUNS078388975
Company NamePORIFEROUS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com
Phone770-683-3855
Emailinfo@poriferous.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100815285020366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FWPProsthesis, Chin, Internal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-03-01

Devices Manufactured by PORIFEROUS, LLC

00815285023565 - SU-POR Surgical Implant2023-08-22 Ramesh Lift Fixation - 2.9mm x 6.25mm x 0.75mm
00815285024494 - SU-POR Surgical Implant2023-08-22 Posterior Fossa Plate - Extra Large - 54mm x 66mm x 1.6mm
00815285023756 - SU-POR Surgical Implant2023-07-18 Extended Ear Wedge Thin - Regular - Right - 15mm x 44mm x 11mm
00815285023763 - SU-POR Surgical Implant2023-07-18 Extended Ear Wedge Thin - Regular - Left - 15mm x 44mm x 11mm
00815285024289 - SU-POR Surgical Implant2023-07-18 Extended Ear Wedge Thin - Large - Right - 15mm x 53mm x 11mm
00815285024296 - SU-POR Surgical Implant2023-07-18 Extended Ear Wedge Thin - Large - Left - 15mm x 53mm x 11mm
00815285023299 - SU-POR Surgical Implant2023-05-30 Nasal Tip Top - 37mm x 22mm x 0.5mm
00815285023336 - SU-POR Surgical Implant2023-05-24 Contoured European Cut Two-Piece Chin - Medium - 60mm x 26mm x 13mm
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.