FDA.reportPublic FDA data

OmniPore Surgical Implant

Primary DI
00852578008281
Brand
OmniPore Surgical Implant
Company
MATRIX SURGICAL HOLDINGS, LLC
Model
OP8339
Device description
Single Piece Ear Implant - Large - Left
Published
2023-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123908000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123908000OMNIPORE SURGICAL IMPLANTS AND ACCESSORIESMatrix Surgical USA2013-07-31KKY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852578008281PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852578008281008525780082818525780082810852578008281

GMDN Terms#

Term, Definition table
TermDefinition
External ear prosthesis, implantableA device intended to be fully- or partially- implanted to reconstruct the external ear by replacing damaged or missing tissue. It is typically made of a polymer material (e.g., solid silicone rubber).

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
079634199
Device count
1
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852578008298Matrix Seiff Ptosis SlingMTX10042025-06-05
00855421005079OmniPore Surgical ImplantOP93122020-04-21
00855421005086OmniPore Surgical Implant OP95412020-04-23
00855421005093OmniPore Surgical Implant OP95422020-04-23
00855421005109OmniPore Surgical Implant OP95432020-04-23
00855421005116OmniPore Surgical Implant OP9544 2020-04-23
00852578008199OmniPore Surgical Implant OP63002023-12-20
00852578008205OmniPore Surgical Implant OP63012023-12-20
00852578008212OmniPore Surgical Implant OP63022023-12-20
00852578008229OmniPore Surgical Implant OP63032023-12-20
00852578008236OmniPore Surgical Implant OP83342023-08-07
00852578008243OmniPore Surgical Implant OP83352023-08-07
00852578008250OmniPore Surgical Implant OP83362023-08-07
00852578008267OmniPore Surgical Implant OP83372023-08-07
00852578008274OmniPore Surgical Implant OP83382023-08-07
00855421005260OmniPore Surgical ImplantOP83282020-04-21
00855421005277OmniPore Surgical ImplantOP83292020-04-21
00855421005284OmniPore Surgical ImplantOP83302020-04-21
00855421005291OmniPore Surgical ImplantOP83312020-04-21
00855421005703OmniPore Surgical ImplantOP83322020-04-21

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