FDA.reportPublic FDA data

SUTUMED

Primary DI
07757093218463
Brand
SUTUMED
Company
Unilene S.A.C.
Model
SDST010TC480
Catalog number
SDST010TC480
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
07757093218470PackageGS112In Commercial Distribution
07757093218463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07757093218470077570932184707757093218470
07757093218463077570932184637757093218463

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
00381780363883Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGAP2017-01-05
04038653826230SilkamB BRAUN SURGICAL SAGAP2015-11-12
04038653826469SilkamB BRAUN SURGICAL SAGAP2015-11-01
04038653826513SilkamB BRAUN SURGICAL SAGAP2015-11-01
04038653741502SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741526SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741601SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741700SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741786SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741816SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741830SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741854SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741892SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741915SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742196SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742257SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742271SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742776SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742936SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742950SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742974SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653742998SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741243SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741281SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741403SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741441SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653741625SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743131SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743438SilkamB BRAUN SURGICAL SAGAP2015-08-20
04038653743414SilkamB BRAUN SURGICAL SAGAP2015-08-20