FDA.reportPublic FDA data

TiMESH

Primary DI
04042301097606
Brand
TiMESH
Company
pfm medical titanium gmbh
Model
6000312
Device description
"Ti-Mesh 6"" X 6"" Light 35g/m²"
Published
2020-06-02
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
FTLMesh, Surgical, Polymeric
OXJMesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTLMesh, Surgical, PolymericGeneral, Plastic Surgery2
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
04042301097613PackageGS13In Commercial Distribution
04042301097606PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042301097613040423010976134042301097613
04042301097606040423010976064042301097606

GMDN Terms#

Term, Definition table
TermDefinition
Pelvic organ prolapse surgical mesh, composite-polymerA woven/knitted or porous material comprised of both a bioabsorbable polymer (e.g., poliglecaprone 25) and a non-bioabsorbable polymer (e.g., polypropylene) intended to be permanently implanted into a female patient for reinforcement and/or bridging of the supporting tissues of the pelvic floor for the surgical treatment of vaginal pelvic organ prolapse (POP), including anterior, posterior, or apical prolapse repair. It is typically available with various material attributes (e.g., density, pore size, weave) and may be pre-configured for specific repair or cut to 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
Lot or batch
true
Expiration date on label
true

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
04042301097590Ti-MESH60003112021-11-01
04042301097637Ti-MESH60002482021-11-01
04042301102775Ti-MESH60004702021-11-01
04042301137173Ti-MESH60004712021-11-01
04042301117793Ti-MESH60004232021-11-01
04042301097552TiMESH60001372019-12-09
04042301097576TiMESH60001382019-12-09
04042301097651TiMESH60001402019-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970461300015TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300022TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300039TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300046TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300053TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300060TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300077TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300084TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300091TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300107TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300114TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300121TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300138TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300145TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300152TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300169TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300176TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300183TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300190TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300206TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300213TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300220TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300237TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300244TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300251TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300268TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300275TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300282TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300299TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22
06970461300305TisuthesShanghai Suokang Medical Implants Co.,Ltd.FTL2026-07-22