FDA.reportPublic FDA data

V-Soft Line BARB BLUNT CANNULA L 21Gx60mm FDA

Primary DI
28800145521134
Brand
V-Soft Line BARB BLUNT CANNULA L 21Gx60mm FDA
Company
Feeltech Co.,Ltd.
Model
L-FTN2162G
Published
2026-03-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
K250107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250107000V-soft Line™ Barbed Surgical Suture (Various)Feeltech Co., Ltd.2025-10-15NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28800145521134PackageGS110In Commercial Distribution
38800145521131PackageGS1300In Commercial Distribution
18800145521137PrimaryGS10
08800145521130Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880014552113428800145521134
3880014552113138800145521131
1880014552113718800145521137
08800145521130088001455211308800145521130

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
688432407
Device count
5
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
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
18800145523377V-Soft Line SCREW 27Gx50mm FDAS27055B2026-03-19
28800145520694V-Soft Line BARB STAR 21Gx60mm FDA2160-101GD2026-03-19
28800145520939V-Soft Line BARB BLUNT CANNULA 23Gx60mm FDAF-FTN2363G2026-03-19
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