FDA.reportPublic FDA data

DemeLENE

Primary DI
10652927785392
Brand
DemeLENE
Company
Demetech Corporation
Model
PM1196013G0P
Device description
Synthetic, Monofilament , Nonabsorbable Suture
Published
2023-08-22
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
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K043330000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043330000POLYPROPILENE SURGICAL SUTURESDemetech Corp.2005-05-16GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30652927785396PackageGS112In Commercial Distribution
10652927785392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3065292778539630652927785396
1065292778539210652927785392

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
3058241048info@demetech.us

Regulatory Flags#

DUNS number
039436691
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10652927777540DemeFORCEFR390226B0P2026-04-20
10652927778240DemeFORCEFR312022026-04-20
10652927778257DemeFORCEFR312052026-04-20
10652927778264DemeFORCEFR312202026-04-20
10652927778271DemeFORCEFR35022026-04-20
10652927778288DemeFORCEFR35052026-04-20
10652927778295DemeFORCEFR35202026-04-20
10652927784890DemeDIOX BarbedPXB2982026B0U12026-04-20
10652927784951DemeDIOX BarbedPXB2983026B0U12026-04-20
10652927785132DemeDIOX BarbedPXB280148C0B2026-04-20
10652927785569DemeDIOX BarbedPXB883017B0U12026-04-20
10652927785606DemeFORCEFR350240B5P2026-04-20
10652927785613DemeFORCEFR4x350548B6P2026-04-20
10652927785644DemeDIOX BarbedPXB1182026B0U12026-04-20
10652927785651DemeDIOX BarbedPXB1183026B0U12026-04-20
10652927785699DemeDIOX BarbedPXB880037B0U12026-04-20
10652927785705DemeDIOX BarbedPXB882037B0U12026-04-20
10652927785835DemeDIOX BarbedPXB180140B0U12026-04-20
10652927785842DemeDIOX BarbedPXB180148B0U12026-04-20
10652927785965DemeDIOX BarbedPXB5383026B0U12026-04-20

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
10705031091467PROLENEETHICON, LLCGAW2026-08-17
10705031091474PROLENEETHICON, LLCGAW2026-08-17
10705031091764PROLENEETHICON, LLCGAW2026-08-17
10705031095045PROLENEETHICON, LLCGAW2026-08-17
10705031095359PROLENEETHICON, LLCGAW2026-08-17
10705031096325PROLENEETHICON, LLCGAW2026-08-17
10705031097278PROLENEETHICON, LLCGAW2026-08-17
10705031097643PROLENEETHICON, LLCGAW2026-08-17
10705031097698PROLENEETHICON, LLCGAW2026-08-17
10705031097896PROLENEETHICON, LLCGAW2026-08-17
10705031097919PROLENEETHICON, LLCGAW2026-08-17
10705031097995PROLENEETHICON, LLCGAW2026-08-17
10705031098008PROLENEETHICON, LLCGAW2026-08-17
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