FDA.report

SU-POR Surgical Implant

Primary DI
00815285020564
Brand
SU-POR Surgical Implant
Company
PORIFEROUS, LLC
Model
4225
Catalog number
4225
Device description
Inferior 2/3 Orbit - Right - 108mm x 75mm
Published
2016-02-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FWPProsthesis, Chin, Internal

Product Code Classifications

CodeDeviceSpecialtyClass
FWPProsthesis, Chin, InternalGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815285020564PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00815285020564008152850205648152850205640815285020564

GMDN Terms

TermDefinition
Polyethylene craniofacial tissue reconstructive materialA sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
770-683-3855info@poriferous.com

Regulatory Flags

DUNS number
078388975
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00815285025071SU-POR Surgical Implant476747672026-01-13
00815285025088SU-POR Surgical Implant476847682026-01-13
00815285025132SU-POR Surgical Implant476547652026-01-13
00815285025149SU-POR Surgical Implant476647662026-01-13
00815285025156SU-POR Surgical Implant476947692026-01-13
00815285025163SU-POR Surgical Implant477047702026-01-13
00815285024869SU-POR Surgical Implant471847182025-09-17
00815285025064SU-POR Surgical Implant471947192025-09-17
00815285024883SU-POR Surgical Implant475347532025-07-17
00815285024890SU-POR Surgical Implant475445742025-07-17
00815285024906SU-POR Surgical Implant475547552025-07-17
00815285024913SU-POR Surgical Implant475647562025-07-17
00815285024944SU-POR Surgical Implant472747272025-07-08
00815285025057SU-POR Surgical Implant472647262025-07-08
00815285024951SU-POR Surgical Implant472347232025-03-07
00815285025446SU-POR Surgical Implant472247222025-03-07
00815285024371SU-POR Surgical Implant439943992025-02-07
00815285024388SU-POR Surgical Implant442044202025-02-07
00815285024968SU-POR Surgical Implant439843982025-02-07
00815285024838SU-POR Surgical Implant469146912025-01-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
B490400102Chin ImplantAartFWP2025-08-28
B490400103Chin ImplantAartFWP2025-08-28
B490400104Chin ImplantAartFWP2025-08-28
B490400201Chin ImplantAartFWP2025-08-28
B490400202Chin ImplantAartFWP2025-08-28
B490400301Chin ImplantAartFWP2025-08-28
B490400302Chin ImplantAartFWP2025-08-28
B490400303Chin ImplantAartFWP2025-08-28
B490400401Chin ImplantAartFWP2025-08-28
B490400402Chin ImplantAartFWP2025-08-28
B490400403Chin ImplantAartFWP2025-08-28
B490400404Chin ImplantAartFWP2025-08-28
B490400101Chin ImplantAartFWP2025-07-31
00888233026932HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233057158HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233057165HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233057172HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233057189HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233057196HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233062244HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233062695HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233062701HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233062718HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233063067HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233063111HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233063241HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233063845HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233064224HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233064446HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04
00888233064491HTR-PMIBIOMET MICROFIXATION, INCFWP2024-06-04