FDA.reportPublic FDA data

SUTUMED

Primary DI
07757093023760
Brand
SUTUMED
Company
Unilene S.A.C.
Model
SDPP010MC360
Published
2023-01-07
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
GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, 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
07757093059189PackageGS112In Commercial Distribution
07757093023760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07757093059189077570930591897757093059189
07757093023760077570930237607757093023760

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
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
07757093024439SUTUMEDSDPP020TC4002023-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04046955081486OPTILENEB BRAUN SURGICAL SAGAW2019-07-04
04046955081769OPTILENEB BRAUN SURGICAL SAGAW2019-04-30
04046955081905OPTILENEB BRAUN SURGICAL SAGAW2019-04-30
04046964791444OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791468OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791505OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791529OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791543OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791727OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791741OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791765OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791789OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964791840OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964792021OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964792045OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964792182OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964792229OPTILENEB BRAUN SURGICAL SAGAW2018-05-03
04046964709104OPTILENEB BRAUN SURGICAL SAGAW2018-04-23
04046964791901OPTILENEB BRAUN SURGICAL SAGAW2018-04-17
04046964708985OPTILENEB BRAUN SURGICAL SAGAW2016-12-12
04046964791406OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791567OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791581OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791680OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791703OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791826OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791864OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791888OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791925OPTILENEB BRAUN SURGICAL SAGAW2016-12-11
04046964791949OPTILENEB BRAUN SURGICAL SAGAW2016-12-11