FDA.reportPublic FDA data

PROLENE

Primary DI
10705031097643
Brand
PROLENE
Company
ETHICON, LLC
Model
EH7691H
Catalog number
EH7691H
Device description
Blue Monofilament (Polypropylene), Nonabsorbable Surgical Suture
Published
2026-08-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
30705031097647PackageGS136In Commercial Distribution
10705031097643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503109764730705031097647
1070503109764310705031097643

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.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
829465157
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031471863VICRYLVCP1828HVCP1828H2026-08-19
10705031472150Coated VICRYLVCP776DVCP776D2026-08-19
10705031472167Coated VICRYLJ4751GJ4751G2026-08-19
10705031472211VICRYLJ1744GJ1744G2026-08-19
10705031472228VICRYLJ1735GJ1735G2026-08-19
10705031005730PERMA-HAND482T482T2015-09-01
10705031010468ETHILON7707G7707G2015-09-01
10705031010482ETHILON7711G7711G2015-09-01
10705031022461ETHILON9030G9030G2015-09-01
10705031022515ETHILON9033G9033G2015-09-01
10705031027077PROLENED7007D70072015-09-01
10705031030893PROLENED8679D86792015-09-01
10705031031968PROLENED9068D90682015-09-01
10705031032972PROLENED9399D93992015-09-01
10705031033061PROLENED9425D94252015-09-01
10705031026926ETHILOND6906D69062015-09-01
10705031244955STRATAFIXSXPP1A431SXPP1A4312018-01-26
10705031244986STRATAFIXSXPP1A415SXPP1A4152018-01-26
10705031245013STRATAFIXSXPP1A429SXPP1A4292018-01-26
10705031245020STRATAFIXSXPP1A428SXPP1A4282018-01-26

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
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
10705031465046PROLENEETHICON, LLCGAW2026-08-17