FDA.reportPublic FDA data

TiO2Mesh

Primary DI
EBCBMFP1010
Brand
TiO2Mesh
Company
BioCer Entwicklungs-GmbH
Model
MFP101
Catalog number
MFP101
Device description
"TiO2Mesh surgical mesh implant for hernia repair made of 100% Polypropylene with titanium oxide surface coating.Size 6cm x 9cm / 2.4"" x 3.6"""
Published
2018-03-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTLMesh, Surgical, Polymeric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113311000TIO2MESH TMBiocer Entwicklungs GmbH2012-07-17FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBCBMFP1010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbableA sterile, flat or three-dimensional (3-D), woven/knitted or porous material made of one or more non-bioabsorbable synthetic polymers [e.g., polypropylene, polyethylene (PE)] intended to be permanently implanted for abdominal hernia (e.g., inguinal, ventral/incisional, umbilical, femoral) and fascial defect repair applications; it is not intended for extra-abdominal applications and not dedicated to diaphragmatic hernia repair. It is typically available with various material attributes and may be pre-configured or cut to a desired size/shape. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315855531
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EBCBMFP1020TiO2MeshMFP102MFP1022018-03-15
EBCBMFP1030TiO2MeshMFP103MFP1032018-03-15
EBCBMFP1050TiO2MeshMFP105MFP1052018-03-15
EBCBMFP1100TiO2MeshMFP110MFP1102018-03-15
EBCBMFP1110TiO2MeshMFP111MFP1112018-03-15
EBCBMFP1120TiO2MeshMFP112MFP122018-03-15
EBCBMFP1210TiO2MeshMFP121MFP1212018-03-15
EBCBMFP1320TiO2MeshMFP132MFP1322018-03-15
EBCBMFP1330TiO2MeshMFP133MFP1332018-03-15
EBCBMFP1410TiO2MeshMFP141MFP1412018-03-15
EBCBMFP3010TiO2MeshMFP301MFP3012018-03-15
EBCBMFP3320TiO2MeshMFP332MFP3322018-03-15
EBCBMFP3330TiO2MeshMFP333MFP3332018-03-15
EBCBMFP3410TiO2MeshMFP341MFP3412018-03-15
EBCEMFP1310TiO2MeshMFP131MFP1312018-03-15

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