SUTUMED

Primary DI
07757093002123
Brand
SUTUMED
Company
Unilene S.A.C.
Model
SDAG030TC240
Published
2023-01-09
Public version status
New
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
K100780000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100780000VITAL SUTURES, SUTUREX, CIRUGIA PERUANAUnilene Sac2010-12-14NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07757093037545PackageGS112In Commercial Distribution
07757093002123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07757093037545077570930375457757093037545
07757093002123077570930021237757093002123

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, monofilament, non-antimicrobialA 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 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.

Contacts#

Phone, Email table
PhoneEmail
+051()997509089Marthalujan@unilene.com

Regulatory Flags#

DUNS number
934900072
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07757093013747SUTUMEDSDNN001TC360SDNN001TC3602024-09-19
07757093013891SUTUMEDSDNN010MC360SDNN010MC3602024-09-19
07757093049166SUTUMEDSDNN001TC360SDNN001TC3602024-09-19
07757093049319SUTUMEDSDNN010MC360SDNN010MC3602024-09-19
07757093023470SUTUMEDSDPP001MR3602023-01-06
07757093023500SUTUMEDSDPP001MR4002023-01-06
07757093023760SUTUMEDSDPP010MC3602023-01-07
07757093023838SUTUMEDSDPP010MR2602023-01-07
07757093023869SUTUMEDSDPP010MR3602023-01-07
07757093023890SUTUMEDSDPP010MR4002023-01-07
07757093023968SUTUMEDSDPP010RC6002023-01-07
07757093024033SUTUMEDSDPP010TC4002023-01-07
07757093024101SUTUMEDSDPP020MC2602023-01-07
07757093024118SUTUMEDSDPP020MC3502023-01-07
07757093024125SUTUMEDSDPP020MC3602023-01-07
07757093024217SUTUMEDSDPP020MR2602023-01-07
07757093024255SUTUMEDSDPP020MR3502023-01-07
07757093024330SUTUMEDSDPP020RC6002023-01-07
07757093024361SUTUMEDSDPP020TC1902023-01-07
07757093024385SUTUMEDSDPP020TC2402023-01-07

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
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
07757093000693SUTUMEDUnilene S.A.C.GAN2023-01-07