FDA.reportPublic FDA data

V-Soft Line SCREW 27Gx50mm FDA

Primary DI
18800145523377
Brand
V-Soft Line SCREW 27Gx50mm FDA
Company
Feeltech Co.,Ltd.
Model
S27055B
Published
2026-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K251414000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251414000Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)Feeltech Co., Ltd.2025-10-20NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28800145523374PackageGS110In Commercial Distribution
38800145523371PackageGS1300In Commercial Distribution
18800145523377PrimaryGS10
08800145523370Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880014552337428800145523374
3880014552337138800145523371
1880014552337718800145523377
08800145523370088001455233708800145523370

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.

Regulatory Flags#

DUNS number
688432407
Device count
5
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
08800145524667JBP Nanocannula 23Gx40mmFTMN23-402026-04-16
18800145520697V-Soft Line BARB STAR 21Gx60mm FDA2160-101GD2026-03-19
18800145520932V-Soft Line BARB BLUNT CANNULA 23Gx60mm FDAF-FTN2363G2026-03-19
18800145521137V-Soft Line BARB BLUNT CANNULA L 21Gx60mm FDAL-FTN2162G2026-03-19
18800145521175V-Soft Line BARB BLUNT CANNULA L 21Gx90mm FDAL-FTN2192G2026-03-19
18800145521854V-Soft Line BARB BLUNT CANNULA L 19Gx40mm FDALC-FTN1942G2026-03-19
18800145522134V-Soft Line ARTE2 18Gx100mm FDA4PS118191603G2026-03-19
18800145522813V-Soft Line MONO 27Gx50mm FDA27055B2026-03-19
18800145523094V-Soft Line MONO 29Gx50mm FDA29056B2026-03-19
28800145520694V-Soft Line BARB STAR 21Gx60mm FDA2160-101GD2026-03-19
28800145520939V-Soft Line BARB BLUNT CANNULA 23Gx60mm FDAF-FTN2363G2026-03-19
28800145521134V-Soft Line BARB BLUNT CANNULA L 21Gx60mm FDAL-FTN2162G2026-03-19
28800145521172V-Soft Line BARB BLUNT CANNULA L 21Gx90mm FDAL-FTN2192G2026-03-19
28800145521851V-Soft Line BARB BLUNT CANNULA L 19Gx40mm FDALC-FTN1942G2026-03-19
28800145522131V-Soft Line ARTE2 18Gx100mm FDA4PS118191603G2026-03-19
28800145522810V-Soft Line MONO 27Gx50mm FDA27055B2026-03-19
28800145523091V-Soft Line MONO 29Gx50mm FDA29056B2026-03-19
28800145523374V-Soft Line SCREW 27Gx50mm FDAS27055B2026-03-19
18800145524190Miracu FCL FORTE 18Gx100mm 3BE18101800G2026-02-26
18800145524206Miracu FCL FORTE 19Gx70mm 3BE19071620G2026-02-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08904255256422PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255256637PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255256743PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255257252PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255257269PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255257276PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-05
08904255234277PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234284PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234291PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234307PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234314PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04
08904255234321PINION™ PDO Knotless SutureMERIL ENDO SURGERY PRIVATE LIMITEDNEW2026-05-04