FDA.reportPublic FDA data

TiMESH

Primary DI
04042301097576
Brand
TiMESH
Company
pfm medical titanium gmbh
Model
6000138
Device description
Ti-Mesh 4" X 6" Light 35 g/m²
Published
2019-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall DefectsGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K031225000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K031225000TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004Gfe Medizintechnik GmbH2003-09-29FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042301097576PackageGS13In Commercial Distribution
04042301097569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042301097576040423010975764042301097576
04042301097569040423010975694042301097569

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

Contacts#

Phone, Email table
PhoneEmail
7607588749regulatory@pfmmedicalusa.com

Regulatory Flags#

DUNS number
344675942
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042301097545TiMESH60001372019-12-09
04042301097569TiMESH60001382019-12-09
04042301097644TiMESH60001402019-12-09
04042301144317TiMESH60007372019-12-09
04042301144331TiMESH60007382019-12-09
04042301097668TiMESH60001392019-12-09
04042301097583Ti-MESH60003112021-11-01
04042301097620Ti-MESH60002482021-11-01
04042301102768Ti-MESH60004702021-11-01
04042301117397Ti-MESH60004712021-11-01
04042301117786Ti-MESH60004232021-11-01
04042301117809Ti-MESH60004242021-11-01
04042301097606TiMESH60003122020-06-02
04042301097590Ti-MESH60003112021-11-01
04042301097637Ti-MESH60002482021-11-01
04042301102775Ti-MESH60004702021-11-01
04042301137173Ti-MESH60004712021-11-01
04042301117793Ti-MESH60004232021-11-01
04042301097552TiMESH60001372019-12-09
04042301097651TiMESH60001402019-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04042301097583Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301097620Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301102768Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301117397Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301117786Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301117809Ti-MESHpfm medical titanium gmbhOXJ2021-11-01
04042301097606TiMESHpfm medical titanium gmbhOXJ2020-06-02
04042301097545TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097569TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097644TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301144317TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301144331TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097552TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097651TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301097668TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301144324TiMESHpfm medical titanium gmbhOXJ2019-12-09
04042301144348TiMESHpfm medical titanium gmbhOXJ2019-12-09
EBCBMFP1320TiO2MeshBioCer Entwicklungs-GmbHOXJ2018-03-15
EBCBMFP1330TiO2MeshBioCer Entwicklungs-GmbHOXJ2018-03-15
EBCBMFP1410TiO2MeshBioCer Entwicklungs-GmbHOXJ2018-03-15
EBCEMFP1310TiO2MeshBioCer Entwicklungs-GmbHOXJ2018-03-15
03700296903265SURGIMESH®XBASPIDE MEDICALOXJ2015-10-23
03700296903272SURGIMESH®XBASPIDE MEDICALOXJ2015-10-23
03700296903289SURGIMESH®XBASPIDE MEDICALOXJ2015-10-23
03700296903296SURGIMESH®XBASPIDE MEDICALOXJ2015-10-23
00850012832218Freedom - Ventral Hernia Repair SystemINSIGHTRA MEDICAL, INC.OXJ2015-07-22
00850012832287Freedom - Ventral Hernia Repair SystemINSIGHTRA MEDICAL, INC.OXJ2015-07-22
00850012832317Freedom - Ventral Hernia Repair SystemINSIGHTRA MEDICAL, INC.OXJ2015-07-22
00837654352960Freedom - Ventral Hernia Repair SystemINSIGHTRA MEDICAL, INC.OXJ2015-07-22
00850012832256Freedom - Ventral Hernia Repair SystemINSIGHTRA MEDICAL, INC.OXJ2015-07-22