SU-POR Surgical Implant 4605

GUDID 00815285023831

Su-Por Ear 4605 - Right - 58mm x 38mm x 32mm

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
Primary Device ID00815285023831
NIH Device Record Keye0ea9aa5-7f51-4670-a229-65131b146007
Commercial Distribution StatusIn Commercial Distribution
Brand NameSU-POR Surgical Implant
Version Model Number4605
Catalog Number4605
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100815285023831 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-09
Device Publish Date2022-08-01

On-Brand Devices [SU-POR Surgical Implant]

00815285021790Nasal Shell - Regular - 38mm x 21mm x 17mm
00815285021783Ear Wedge - Left - 15mm x 44mm x 11mm
00815285021776Ear Wedge - Right - 15mm x 44mm x 11mm
00815285021769Cranial Patient-Specific Implant
00815285021752Membrane Sheet - 38mm x 50mm x 0.60mm
00815285021745Sellar Floor - Large - Membrane - 40mm x 40mm x 2.5mm x 0.73mm
00815285021738Sellar Floor - Regular - 20mm x 20mm x 2.5mm x 0.45mm
00815285021721Cranial Hemisphere - Right - 124mm x 170mm x 6.0mm
00815285021714Cranial Hemisphere - Left - 124mm x 170mm x 6.0mm
00815285021707Cranial Hemisphere - Right - 124mm x 170mm x 4.5mm
00815285021691Cranial Hemisphere - Left - 124mm x 170mm x 4.5mm
00815285021684Cranial Dome - 150mm x 180mm x 6mm
00815285021677Cranial Dome - 150mm x 180mm x 4mm
00815285021660Burr Hole Cover - 3 per package - 29mm x 7mm x 14mm
00815285021653Burr Hole Cover - 3 per package - 15mm x 3mm x 5mm
00815285021646Flex Sheet - with membrane - 56mm x 91mm x 4mm
00815285021639Flex Sheet - without membrane - 56mm x 91mm x 4mm
00815285021622Temporal Flex Grid - Large - Right - 82mm x 105mm x 20mm
00815285021615Temporal Flex Grid - Large - Left - 82mm x 105mm x 20mm
00815285021608Temporal Flex Grid - Medium - Right - 74mm x 93mm x 20mm
00815285021592Temporal Flex Grid - Medium - Left - 74mm x 93mm x 20mm
00815285021585Temporal Flex Grid - Small - Right - 61mm x 78mm x 18mm
00815285021578Temporal Flex Grid - Small - Left - 61mm x 78mm x 18mm
00815285021561Cranial Flex Grid - 97mm x 106mm x 6mm
00815285021554Mastoid - Right - 58mm x 56mm x 1.5mm
00815285021547Mastoid - Left- 58mm x 56mm x 1.5mm
00815285021530Mastoid - Small - 36mm x 45mm x 1mm
00815285021523Pterional - Right - 6mm x 43mm x 44mm
00815285021516Pterional - Left - 6mm x 43mm x 44mm
00815285021509Nasal Dorsum - Large - 67mm x 9mm x 14mm
00815285021493Nasal Dorsum - Small - 54mm x 6mm x 11mm
00815285021486Nasal Dorsum - Tapered - 55mm x 6mm x 9mm
00815285021479Nasal Arch - 70mm x 17mm x 2mm
00815285021462Nasal Arch - 70mm x 15mm x 2mm
00815285021455Nasal Arch - 70mm x 13mm x 2mm
00815285021448Nasal Radix - 24mm x 3mm x 10mm
00815285021431Nasal Sheet - 30mm x 9.0mm x 1.1mm
00815285021424Nasal Batten (2 per package) 25mm x 12.5mm x 0.60mm
00815285021417Nasal Dorsal Shell - 43mm x 16mm x 22mm
00815285021400Block - 38mm x 63mm x 9.5mm
00815285021394Block - 25mm x 50mm x 9.5mm
00815285021387Block - 13mm x 38mm x 9.5mm
00815285021370Block - 38mm x 63mm x 6mm
00815285021363Block - 25mm x 50mm x 6mm
00815285021356Block - 13mm x 38mm x 6mm
00815285021349Block - 38mm x 63mm x 3mm
00815285021332Block - 25mm x 50mm x 3mm
00815285021325Block - 13mm x 38mm x 3mm
00815285021318Auricular Helical Rim - Right - 37mm x 62mm
00815285021301Auricular Helical Rim - Left - 37mm x 62mm
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