FDA.reportPublic FDA data

Biopor®

Primary DI
UML30520
Brand
Biopor®
Company
CEREMED, INC.
Model
UML-3052
Catalog number
UML-3052
Device description
Small Malar Left
Published
2016-07-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
UML30520PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter

Contacts#

Phone, Email table
PhoneEmail
310-815-2125info@ceremed.com

Regulatory Flags#

DUNS number
626959824
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
UCR40640Biopor®UCR-4064UCR-40642016-07-20
UCR60640Biopor®UCR-6064 UCR-6064 2016-07-20
UCR90640Biopor®UCR-9064UCR-90642016-07-20
UCS40640Biopor®UCS-4064UCS-40642016-07-20
UCS60640Biopor®UCS-6064 UCS-6064 2016-07-20
UCS90640Biopor®UCS-9064UCS-90642016-07-20
UML45520Biopor®UML-4552UML-45522016-07-20
UML60520Biopor®UML-6052UML-60522016-07-20
UMR30520Biopor®UMR-3052UMR-30522016-07-20
UMR45520Biopor®UMR-4552UMR-45522016-07-20
UMR60520Biopor®UMR-6052UMR-60522016-07-20
USH05540Biopor®USH-0554USH-05542016-07-20
USH05580Biopor®USH-0558USH-05582016-07-20
USH08540Biopor®USH-0854USH-08542016-07-20
USH08580Biopor®USH-0858USH-08582016-07-20
USH15540Biopor®USH-1554USH-15542016-07-20
USH15580Biopor®USH-1558USH-15582016-07-20
USH30540Biopor®USH-3054USH-30542016-07-20
USH30580Biopor®USH-3058USH-30582016-07-20
USL30520Biopor®USL-3052USL-30522016-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810188324542HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-05-14
00810188323965HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-04-16
00810188323972HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2026-04-16
00810188322555HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2025-10-23
00810188322562HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2025-10-23
00810128537384HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2024-09-09
00810128531702HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-08-08
00810128531795HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-07-25
00810128530149HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-03-13
00810128530156HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-03-13
00810077249741HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-02-16
00810077249284HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-01-18
00810077248959HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2023-01-04
00810077247471HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247488HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-15
00810077247518HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-09-08
00810077245828HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-06-21
00810077245675HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-05-20
00810077244937HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-04-20
00810077243312HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-01-14
00810077242605HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2022-01-05
00810023928409HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2021-01-22
00810023927631HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-11-09
00810023925477HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-06-23
00810023924920HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-04-30
00810023923589HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2020-02-24
00810023920984HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-20
00810023920854HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-08-15
00810042038486HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2019-03-21
00810042036857HTR-PEKKOXFORD PERFORMANCE MATERIALS, INC.KKY2018-12-03