FDA.reportPublic FDA data

SUTUMED

Primary DI
07757093028222
Brand
SUTUMED
Company
Unilene S.A.C.
Model
SDST001MR400
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
GAPSuture, Nonabsorbable, Silk

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAPSuture, Nonabsorbable, SilkGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123034000VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMEDUnilene Sac2013-05-28GAR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07757093063643PackageGS112In Commercial Distribution
07757093028222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07757093063643077570930636437757093063643
07757093028222077570930282227757093028222

GMDN Terms#

Term, Definition table
TermDefinition
Silk suture"A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a ""non-bioabsorbable"" material, it may be digested by proteolysis after an extended period of time. 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
07757093028192SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028260SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028536SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028734SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028833SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028888SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028956SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093028987SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029014SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029236SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029366SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029373SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029427SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029489SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029502SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029540SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029564SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029595SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029601SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093218463SUTUMEDUnilene S.A.C.GAP2023-01-09
07757093029809SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029854SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029878SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093029892SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030027SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030089SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030256SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030294SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030331SUTUMEDUnilene S.A.C.GAP2023-01-06
07757093030461SUTUMEDUnilene S.A.C.GAP2023-01-06