FDA.reportPublic FDA data

SUTUMED

Primary DI
07757093049166
Brand
SUTUMED
Company
Unilene S.A.C.
Model
SDNN001TC360
Catalog number
SDNN001TC360
Published
2024-09-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GARSuture, Nonabsorbable, Synthetic, Polyamide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GARSuture, Nonabsorbable, Synthetic, PolyamideGeneral, 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
07757093049166PackageGS112In Commercial Distribution
07757093013747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07757093049166077570930491667757093049166
07757093013747077570930137477757093013747

GMDN Terms#

Term, Definition table
TermDefinition
Nylon suture, non-bioabsorbable, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) 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. The thread provides temporary wound support until the wound sufficiently heals. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+051997509089marthalujan@unilene.com

Regulatory Flags#

DUNS number
934900072
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07757093013747SUTUMEDSDNN001TC360SDNN001TC3602024-09-19
07757093013891SUTUMEDSDNN010MC360SDNN010MC3602024-09-19
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
07757093024439SUTUMEDSDPP020TC4002023-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00848782052516SharpointSurgical Specialties México, S. de R.L. de C.V.GAR2026-08-26
10705031089020ETHILONETHICON, LLCGAR2026-08-25
10705031096479ETHILONETHICON, LLCGAR2026-08-25
00816848022964SUPRAMIDS JACKSON INCGAR2026-08-21
00816848022988SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023008SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023329SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023343SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023367SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023381SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023527SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023541SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023664SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023688SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023787SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023800SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023824SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023848SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023862SUPRAMIDS JACKSON INCGAR2026-08-21
00816848023886SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023947SUPRAMID EXTRAS JACKSON INCGAR2026-08-21
00816848023954SUPRAMIDS JACKSON INCGAR2026-08-21
00816848024029SUPRAMIDS JACKSON INCGAR2026-08-21
08903837402325TrulonHEALTHIUM MEDTECH LIMITEDGAR2026-08-19
08903837799326TrulonHEALTHIUM MEDTECH LIMITEDGAR2026-08-19
10705031245587ETHILONETHICON, LLCGAR2026-08-17
10705031245624ETHILONETHICON, LLCGAR2026-08-17
10705031465374ETHILONETHICON, LLCGAR2026-08-17
10705031465381ETHILONETHICON, LLCGAR2026-08-17
10705031465404ETHILONETHICON, LLCGAR2026-08-17