FDA.reportPublic FDA data

PROLENE

Primary DI
10705031231238
Brand
PROLENE
Company
ETHICON, LLC
Model
EP8776H
Catalog number
EP8776H
Device description
Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
Published
2015-09-01
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
K133356000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133356000PROLENE POLYPROPYLENE NONABSORBABLE SUTUREETHICON, Inc.2013-12-06GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031231232PackageGS136In Commercial Distribution
10705031231238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503123123230705031231232
1070503123123810705031231238

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene, 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
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
829465157
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031023369PERMA-HANDC004DC004D2015-09-01
10705031023727NUROLONC503DC503D2015-09-01
10705031023741NUROLONC512DC512D2015-09-01
10705031023758NUROLONC513DC513D2015-09-01
10705031023765NUROLONC514DC514D2015-09-01
10705031023888NUROLONC553DC553D2015-09-01
10705031023895NUROLONC554DC554D2015-09-01
10705031023918NUROLONC563DC563D2015-09-01
10705031023987NUROLONC584DC584D2015-09-01
10705031024199ETHIBOND EXCELCX12DCX12D2015-09-01
10705031024205ETHIBOND EXCELCX13DCX13D2015-09-01
10705031088054ETHILON1628H1628H2026-07-03
10705031089600ETHILON648H648H2026-07-03
10705031097018ETHILONEH7553HEH7553H2026-07-03
10705031099975ETHILONFH5171HFH5171H2026-07-03
17891338994365VICRYL RAPIDEVR1626GVR1626G2026-07-03
17891338994389VICRYL RAPIDEVR1824HVR1824H2026-07-03
17891338994396VICRYL RAPIDEVR1828HVR1828H2026-07-03
17891338994440VICRYL RAPIDEVR1916GVR1916G2026-07-03
17891338994457VICRYL RAPIDEVR4890GVR4890G2026-07-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08903837037824TruleneHEALTHIUM MEDTECH LIMITEDGAW2024-07-11
07757093024767SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024828SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024859SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093024873SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025092SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025115SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025146SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025184SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025290SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025313SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025467SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025610SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025702SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025726SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025740SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093025832SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026044SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026136SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026150SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026280SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093026518SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093680543SUTUMEDUnilene S.A.C.GAW2023-01-09
07757093023760SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023838SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023869SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023890SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093023968SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024033SUTUMEDUnilene S.A.C.GAW2023-01-07
07757093024101SUTUMEDUnilene S.A.C.GAW2023-01-07