FDA.reportPublic FDA data

Coated VICRYL

Primary DI
10705031040533
Brand
Coated VICRYL
Company
Ethicon Inc.
Model
J494H
Catalog number
J494H
Device description
Undyed Braided (Polyglactin 910), Synthetic Absorbable Suture
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022269000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022269000COATED VICRYL* (POLYGLACTIN 910) SUTUREETHICON, Inc.2002-09-13GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031040537PackageGS136In Commercial Distribution
10705031040533PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503104053730705031040537
1070503104053310705031040533

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. 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
002144145
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031462571VISTASEALVSTL35VSTL352019-10-01
10705031462724VISTASEALVSTL45VSTL452019-10-01
10705031462533VISTASEALVSTAS1VSTAS1, VSTAS1E2019-10-01
10705031131958ETHICONMS1995MS19952015-09-23
10705031005235BIOPATCH415041502016-06-20
10705031005242BIOPATCH415141512016-06-20
10705031005259BIOPATCH415241522016-06-20
10705031029309ETHIBOND EXCELD8150D81502015-09-01
10705031030572ETHIBOND EXCELD8572D85722015-09-01
10705031058552ETHIBOND EXCELX997GX997G2015-09-01
10705031088351MERSILENE1765G1765G2020-04-14
10705031204553ETHIBOND EXCELD8573D85732015-09-01
10705031206403ENDOKNOTEX10GEX10G2015-09-25
10705031049703MERSILENER833HR833H2015-09-01
10705031001107BIOPATCH10150101502016-07-18
10705031001114BIOPATCH10151101512016-06-20
10705031001121BIOPATCH10152101522016-06-20
10705031036826ETHICONDW31BDW31B2015-09-01
10705031206427ENDOLOOPEZ10GEZ10G2015-09-24
10705031206458ENDOKNOTJK10GJK10G2015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08903837224491MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337214MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837337252PDSYNTHHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837402349TruglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799265MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799289MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
08903837799302MonoglydeHEALTHIUM MEDTECH LIMITEDGAM2026-08-19
10705031471863VICRYLETHICON, LLCGAM2026-08-19
10705031472150Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472167Coated VICRYLETHICON, LLCGAM2026-08-19
10705031472211VICRYLETHICON, LLCGAM2026-08-19
10705031472228VICRYLETHICON, LLCGAM2026-08-19
10705031464278STRATAFIXETHICON, LLCGAM2023-03-24
10705031464285STRATAFIXETHICON, LLCGAM2023-03-24
10705031464292STRATAFIXETHICON, LLCGAM2023-03-24
10705031464308STRATAFIXETHICON, LLCGAM2023-03-24
10705031464315STRATAFIXETHICON, LLCGAM2023-03-24
10705031464322STRATAFIXETHICON, LLCGAM2023-03-24
10705031464339STRATAFIXETHICON, LLCGAM2023-03-24
10705031464346STRATAFIXETHICON, LLCGAM2023-03-24
10705031464353STRATAFIXETHICON, LLCGAM2023-03-24
10705031464360STRATAFIXETHICON, LLCGAM2023-03-24
10705031464377STRATAFIXETHICON, LLCGAM2023-03-24
10705031464384STRATAFIXETHICON, LLCGAM2023-03-24
10705031464391STRATAFIXETHICON, LLCGAM2023-03-24
10705031464407STRATAFIXETHICON, LLCGAM2023-03-24
10705031464414STRATAFIXETHICON, LLCGAM2023-03-24
10705031464421STRATAFIXETHICON, LLCGAM2023-03-24
10705031464438STRATAFIXETHICON, LLCGAM2023-03-24