FDA.reportPublic FDA data

MINT

Primary DI
08809204330348
Brand
MINT
Company
Hans Biomed Corp.
Model
MINI-S 1017
Published
2017-07-18
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

Product Codes#

Code, Name table
CodeName
NEWSuture, Surgical, Absorbable, Polydioxanone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEWSuture, Surgical, Absorbable, PolydioxanoneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130191000MINTHans Biomed Corporation2013-06-12NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809204330348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809204330348088092043303488809204330348

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
689512625
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809963474109MINT MONO SuturesMINT 50HN2538A2026-10-20
08809963474116MINT MONO SuturesMINT 50HN2938A2026-10-20
08809963474123MINT MONO SuturesMINT 50HN3038A2026-10-20
08809963478428MINT MONO SuturesMINT 90HN2760A2026-10-20
08809963478435MINT MONO SuturesMINT 50HN2738A2026-10-20
08809963478459MINT MONO SuturesMINT 70HN2550A2026-10-20
08809204338498ExponentEXP002017-03-09
08809204338580TruForm+TFP003DEMO2017-07-18
08809204338597TruForm+TFP005DEMO2017-07-18
08809204338603TruForm+TFP010DEMO2017-07-18
08809204338610TruForm+TFP030DEMO2017-07-18
08809204338627TruForm+TFP050DEMO2017-07-18
08809204338634TruForm+TFP100DEMO2017-07-18
08809204338641TruForm+TFG010DEMO2017-07-18
08809204338658TruForm+TFG030DEMO2017-07-18
08809204338665TruForm+TFG050DEMO2017-07-18
08809204338672TruForm+TFG100DEMO2017-07-18
08809204338689TruFormFP003DEMO2017-07-18
08809204338696TruFormFP005DEMO2017-07-18
08809204338702TruFormFP010DEMO2017-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809963474109MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963474116MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963474123MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963478428MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963478435MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
08809963478459MINT MONO SuturesHans Biomed Corp.NEW2026-10-20
18800145524299Miracu FCL LSCO 19Gx45mmFeeltech Co.,Ltd.NEW2026-08-25
18800145525913JBP V Line Edge 19Gx45mmFeeltech Co.,Ltd.NEW2026-08-25
18800145525920JBP V Line Force 19Gx70mmFeeltech Co.,Ltd.NEW2026-08-25
08809963477384MINTHans Biomed Corp.NEW2026-07-28
08809963477445MINTHans Biomed Corp.NEW2026-07-28
08809963477858MINTHans Biomed Corp.NEW2026-07-28
08904255243903PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255244009PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255244016PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255247628PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255247697PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255250536PINION™ PDO Knotless SutureThe PINION™ PDO Knotless Suture consists of barbed suMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255250925PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255251021PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255251168PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252141PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252158PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252301PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252318PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252332PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252349PINION™ PGA-PCL Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252370PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255252820PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255253049PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05