MONOCRYL

Primary DI
10705031059337
Brand
MONOCRYL
Company
ETHICON, LLC
Model
Y494G
Catalog number
Y494G
Device description
Undyed Monofilament (Poliglecaprone 25), Synthetic Absorbable 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
GANSUTURE, ABSORBABLE, SYNTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GANSuture, Absorbable, SyntheticGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K964072000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K964072000MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYEDETHICON, Inc.1996-12-18GAN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705031059331PackageGS112In Commercial Distribution
10705031059337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503105933130705031059331
1070503105933710705031059337

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilamentA single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) 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 needle. 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

Contacts#

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

Regulatory Flags#

DUNS number
079402290
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031002449MERSILENE1762G1762G2015-09-01
10705031002401MERSILENE1760G1760G2015-09-01
10705031009547MERSILENE740G740G2015-09-01
10705031045040PERMA-HANDM13TM13T2015-09-01
10705031047259NUROLONN104TN104T2015-09-01
10705031047273NUROLONN124TN124T2015-09-01
10705031049499MERSILENER495TR495T2015-09-01
10705031049642MERSILENER756GR756G2015-09-01
10705031050006PERMA-HANDSA10GSA10G2015-09-01
10705031050037PERMA-HANDSA5HSA5H2015-09-01
10705031050129PERMA-HANDSA6HSA6H2015-09-01
10705031050143PERMA-HANDSA73HSA73H2015-09-01
10705031050167PERMA-HANDSA74HSA74H2015-09-01
10705031050181PERMA-HANDSA75HSA75H2015-09-01
10705031050204PERMA-HANDSA76GSA76G2015-09-01
10705031050228PERMA-HANDSA77GSA77G2015-09-01
10705031050242PERMA-HANDSA7HSA7H2015-09-01
10705031050310PERMA-HANDSA8HSA8H2015-09-01
10705031050358PERMA-HANDSA9GSA9G2015-09-01
10705031023369PERMA-HANDC004DC004D2015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705031463998MONOCRYLETHICON, LLCGAN2023-08-28
10705031470354MONOCRYLETHICON, LLCGAN2023-08-28
10705031470361MONOCRYLETHICON, LLCGAN2023-08-28
10705031470385MONOCRYLETHICON, LLCGAN2023-08-28
10705031470392MONOCRYLETHICON, LLCGAN2023-08-28
10705031059764MONOCRYLETHICON, LLCGAN2023-05-17
10705031135017MONOCRYLETHICON, LLCGAN2023-05-17
10705031135024MONOCRYLETHICON, LLCGAN2023-05-17
10705031135031MONOCRYLETHICON, LLCGAN2023-05-17
07757093001539SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001553SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001560SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001621SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001638SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001652SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001683SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001829SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001898SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001959SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001973SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093001997SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093002017SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093002093SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093002123SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093218449SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093218562SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093218586SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093645238SUTUMEDUnilene S.A.C.GAN2023-01-09
07757093002253SUTUMEDUnilene S.A.C.GAN2023-01-08
07757093002284SUTUMEDUnilene S.A.C.GAN2023-01-08