FDA.reportPublic FDA data

BOX

Primary DI
B772DWFB1803
Brand
BOX
Company
MEDYGLOBAL MEDICAL DEVICES SL.
Model
20X1
Catalog number
DWFB-18-03
Device description
PDO TRHREADS BIOABSORBABLE MATERIAL WITH NEEDLE
Published
2021-06-04
Public version status
Update
Distribution status
Not 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
K160761000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160761000DW-1CDongwon Medical Co., Ltd.2016-11-22NEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B772DWFB1803PrimaryHIBCC0
BOXDWFB1803Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polydioxanone/polyethylene sutureA multiple-strand (multifilament), synthetic thread made from strands of bioabsorbable polydioxanone and non-bioabsorbable polyethylene (PE), intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (includes use in orthopaedic surgeries). It is coated with a copolymer and may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
465769007
Device count
20
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B772DWA1912MESH8X1DWA-19-122021-06-07
B772DWA1913MESH8X1DWA-19-132021-06-07
B772DWB1903SUPERTORNADO 20X119GX1002021-06-07
B772DWB2101SCREWCOG20X1DWB-21-012021-06-07
B772DWCB1912RHINO20X1DWCB-19-122021-06-07
B772DWCB1913RHINO20X1DWCB-19-132021-06-07
B772DWFB1801HARPOON20X1DWFB18012021-06-07
B772DWFB1802HARPOON20X1DWFB-18-022021-06-07
B772DWFB1901HARPOON20X1DWFB-19-012021-06-07
B772DWFB1902HARPOON20X1DWFB-19-022021-06-07
B772SC23G360TORNADO10x1SC-23G3-602021-06-07
B772SC23G390TORNADO10X1SC-23G3-902021-06-07
B772SC26G560TORNADO10x1SC-26G5-602021-06-07
B772SC27G538TORNADO10X1SC-27G5-382021-06-07
B772SC27G550TORNADO10x1SC-27G5-502021-06-07
B772SC29G625TORNADO10x1SC-29G6-252021-06-07
B772DWB2102SCREWCOG20X121GX902021-06-04
B772SS23G338TORNADO10x1SS-23G3-382021-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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