FDA.reportPublic FDA data

Rejubeau Stylish FCN V UP Shark 19G x 100mm (W-shape)

Primary DI
18800145507933
Brand
Rejubeau Stylish FCN V UP Shark 19G x 100mm (W-shape)
Company
Feeltech Co.,Ltd.
Model
4PS119101603G
Published
2023-12-20
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
K172602000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172602000MiracuFeeltech Co., Ltd.2018-11-14NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
28800145507930PackageGS110In Commercial Distribution
38800145507937PackageGS1300In Commercial Distribution
18800145507933PrimaryGS10
08800145507936Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2880014550793028800145507930
3880014550793738800145507937
1880014550793318800145507933
08800145507936088001455079368800145507936

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
10
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
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
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

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