FDA.reportPublic FDA data

FILBLOC PERMANENT

Primary DI
18033439169238
Brand
FILBLOC PERMANENT
Company
ASSUT EUROPE SPA
Model
PS028HHAC
Published
2018-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

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
K171039000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171039000Assut Filbloc Permanent SuturesAssut Europe S.P.A.2017-08-29GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18033439169238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1803343916923818033439169238

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 needle intended to be disposed of after single use. 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 intended to be used in a sterile condition.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
654747567
Device count
1
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
38033439007138FILBLOC PERMANENTPZ8902024-08-09
38033439007190FILBLOC PERMANENTPY8912024-08-09
38033439007435FILBLOC PERMANENTPS9202024-08-09
38033439007770FILBLOC PERMANENTPY893K2024-08-09
38033439008968FILBLOC PERMANENTPU5432024-08-09
08033439419145THD Block US8800862025-05-21
08033439416731FILBLOC FS248HHAD/32025-02-19
18033439002382ASSUFILFR8552024-08-09
18033439114085FILBLOC FS412HHAH2024-08-09
18033439168712FILBLOC FQ478HHAH2024-08-09
18033439372812ASSUFILFQ469WBF2024-08-09
18033439374090FILBLOC FU534HHAP2024-08-09
18033439374106FILBLOC FU38EHHAH2024-08-09
38033439003154ASSUFILFU3952024-08-09
38033439003277ASSUFILFS4642024-08-09
38033439003352ASSUFILFR4652024-08-09
38033439003833ASSUFILFW5152024-08-09
38033439003895ASSUFILFV5332024-08-09
38033439004502ASSUFIL MONOFILAMENTOFV386M2024-08-09
38033439004625ASSUFIL MONOFILAMENTOFS464M2024-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031472754STRATAFIXETHICON, LLCGAW2026-10-29
10705031472761STRATAFIXETHICON, LLCGAW2026-10-29
10705031472778STRATAFIXETHICON, LLCGAW2026-10-29
10705031472785STRATAFIXETHICON, LLCGAW2026-10-29
10705031472792STRATAFIXETHICON, LLCGAW2026-10-29
10705031472808STRATAFIXETHICON, LLCGAW2026-10-29
10705031472815STRATAFIXETHICON, LLCGAW2026-10-29
10705031472822STRATAFIXETHICON, LLCGAW2026-10-29
10705031472839STRATAFIXETHICON, LLCGAW2026-10-29
10705031472846STRATAFIXETHICON, LLCGAW2026-10-29
10705031472853STRATAFIXETHICON, LLCGAW2026-10-29
10705031472860STRATAFIXETHICON, LLCGAW2026-10-29
10705031472877STRATAFIXETHICON, LLCGAW2026-10-29
10705031472884STRATAFIXETHICON, LLCGAW2026-10-29
10705031472891STRATAFIXETHICON, LLCGAW2026-10-29
10705031472907STRATAFIXETHICON, LLCGAW2026-10-29
10705031472914STRATAFIXETHICON, LLCGAW2026-10-29
10705031472921STRATAFIXETHICON, LLCGAW2026-10-29
10705031472938STRATAFIXETHICON, LLCGAW2026-10-29
10705031472945STRATAFIXETHICON, LLCGAW2026-10-29
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