FDA.reportPublic FDA data

Duramesh

Primary DI
00850008298080
Brand
Duramesh
Company
Mesh Suture Inc.
Model
MSI-200
Device description
DURAMESH™ 0 Mesh Suture: Small Needle – USA
Published
2023-08-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211178000DURAMESH Mesh SutureMsi2022-09-02GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850008298087PackageGS15In Commercial Distribution
00850008298080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000829808710850008298087
00850008298080008500082980808500082980800850008298080

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, multifilamentA multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-298-5468info@meshsuture.com

Regulatory Flags#

DUNS number
116375032
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850008298097DurameshMSI-2012023-08-31
00850008298103DurameshMSI-3002023-08-31
00850008298110DurameshMSI-3012023-08-31
00850008298127DurameshMSI-5002023-08-31
00850008298134DurameshMSI-5012023-08-31
00850008298073DurameshMSI-1002023-08-31
10850008298094DurameshMSI-2012023-08-31
10850008298100DurameshMSI-3002023-08-31
10850008298117DurameshMSI-3012023-08-31
10850008298124DurameshMSI-5002023-08-31
10850008298131DurameshMSI-5012023-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837224514TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224538TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224552TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837337238TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
10705031091412PROLENEETHICON, LLCGAW2026-08-17
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10705031091764PROLENEETHICON, LLCGAW2026-08-17
10705031095045PROLENEETHICON, LLCGAW2026-08-17
10705031095359PROLENEETHICON, LLCGAW2026-08-17
10705031096325PROLENEETHICON, LLCGAW2026-08-17
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10705031097698PROLENEETHICON, LLCGAW2026-08-17
10705031097896PROLENEETHICON, LLCGAW2026-08-17
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10705031098039PROLENEETHICON, LLCGAW2026-08-17
10705031127838PROLENEETHICON, LLCGAW2026-08-17
10705031128491PROLENEETHICON, LLCGAW2026-08-17
10705031132641PROLENEETHICON, LLCGAW2026-08-17
10705031148284PROLENEETHICON, LLCGAW2026-08-17
10705031148314PROLENEETHICON, LLCGAW2026-08-17
10705031148697PROLENEETHICON, LLCGAW2026-08-17
10705031201965PROLENEETHICON, LLCGAW2026-08-17
10705031201989PROLENEETHICON, LLCGAW2026-08-17
10705031238251PROLENEETHICON, LLCGAW2026-08-17
10705031464995PROLENEETHICON, LLCGAW2026-08-17
10705031465015PROLENEETHICON, LLCGAW2026-08-17