FDA.reportPublic FDA data

DuraSorb Monofilament Mesh

Primary DI
00860000875929
Brand
DuraSorb Monofilament Mesh
Company
SURGICAL INNOVATION ASSOCIATES, INC.
Model
PTM0616
Catalog number
PTM0616
Device description
Monfilament Mesh
Published
2022-08-12
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181094000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181094000Polydioxanone Surgical ScaffoldLntegra Lifesciences2018-08-02FTL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000875929PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000875929008600008759298600008759290860000875929

GMDN Terms#

Term, Definition table
TermDefinition
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbableAn implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
872-870-0520info@sia.health
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
117061618
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860000875943DuraSorb Monofilament MeshPTM2025PTM20252022-08-12
00860000875905DuraSorb Monofilament MeshPTM1025PTM10252019-12-17

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