Home GUDID 30705031464715 STRATAFIX
Primary DI 30705031464715
Brand STRATAFIX
Company ETHICON, LLC
Model SXPP2B417
Catalog number SXPP2B417
Device description Stratafix (Spiral PDS Plus), Bidirectional
Published 2023-08-04
Public version status New
Distribution status In Commercial Distribution
MRI safety MR Safe
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name NEW Suture, surgical, absorbable, polydioxanone
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NEW Suture, Surgical, Absorbable, Polydioxanone General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 30705031464715 Package GS1 12 In Commercial Distribution 10705031464711 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 30705031464715 30705031464715 10705031464711 10705031464711
GMDN Terms# Term, Definition table Term Definition Barbed polyester suture, antimicrobial A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester, and containing an agent to locally inhibit bacterial growth, intended to approximate the edges of a soft-tissue wound or incision by stitching. It is designed with barbs along its length intended to facilitate tissue approximation by adding tension, a fixation feature (e.g., tab, loop, bidirectional barbs) intended to eliminate the need to tie a knot, and may include disposable suture application devices [e.g., needle, passer]. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is absorbed by hydrolysis. This is a single-use device.
Regulatory Flags# DUNS number 829465157 Device count 1 DM exempt false Premarket exempt false HCT/P false Kit false Combination product true Lot or batch true Serial number false Manufacturing date on label false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 28800145520694 V-Soft Line BARB STAR 21Gx60mm FDA Feeltech Co.,Ltd. NEW 2026-03-19 28800145520939 V-Soft Line BARB BLUNT CANNULA 23Gx60mm FDA Feeltech Co.,Ltd. NEW 2026-03-19 28800145521134 V-Soft Line BARB BLUNT CANNULA L 21Gx60mm FDA Feeltech Co.,Ltd. NEW 2026-03-19 28800145521172 V-Soft Line BARB BLUNT CANNULA L 21Gx90mm FDA Feeltech Co.,Ltd. NEW 2026-03-19 28800145521851 V-Soft Line BARB BLUNT CANNULA L 19Gx40mm FDA Feeltech Co.,Ltd. NEW 2026-03-19 28800145522131 V-Soft Line ARTE2 18Gx100mm FDA Feeltech Co.,Ltd. NEW 2026-03-19 28800145522810 V-Soft Line MONO 27Gx50mm FDA Feeltech Co.,Ltd. NEW 2026-03-19 28800145523091 V-Soft Line MONO 29Gx50mm FDA Feeltech Co.,Ltd. NEW 2026-03-19 28800145523374 V-Soft Line SCREW 27Gx50mm FDA Feeltech Co.,Ltd. NEW 2026-03-19 00810126505378 Basik 3D DENTAL DESIGNS AND DEVELOPMENT, LLC NEW 2026-03-05 00817169022466 Basik By 3D Dental 3D DENTAL DESIGNS AND DEVELOPMENT, LLC NEW 2026-03-05 00817169022473 Basik By 3D Dental 3D DENTAL DESIGNS AND DEVELOPMENT, LLC NEW 2026-03-05 00817169022480 Basik By 3D Dental 3D DENTAL DESIGNS AND DEVELOPMENT, LLC NEW 2026-03-05 00817169022497 Basik By 3D Dental 3D DENTAL DESIGNS AND DEVELOPMENT, LLC NEW 2026-03-05 28800145524197 Miracu FCL FORTE 18Gx100mm Feeltech Co.,Ltd. NEW 2026-02-26 28800145524203 Miracu FCL FORTE 19Gx70mm Feeltech Co.,Ltd. NEW 2026-02-26 28800145524210 Miracu FCL FORTE 19Gx100mm Feeltech Co.,Ltd. NEW 2026-02-26 28800145524265 Miracu FCL FORTE FIX 18Gx100mm Feeltech Co.,Ltd. NEW 2026-02-26 28800145524272 Miracu FCL FORTE FIX 19Gx70mm Feeltech Co.,Ltd. NEW 2026-02-26 28800145524302 Miracu FCV Line 17Gx70mm Feeltech Co.,Ltd. NEW 2026-02-26 28800145524319 iracu FCV Line 17Gx100mm Feeltech Co.,Ltd. NEW 2026-02-26 28800145524395 Miracu MONO 27Gx40mm FDA Feeltech Co.,Ltd. NEW 2026-02-26 28800145524401 Miracu MONO 27Gx50mm FDA Feeltech Co.,Ltd. NEW 2026-02-26 28800145524425 Miracu MONO 27Gx60mm FDA Feeltech Co.,Ltd. NEW 2026-02-26 28800145524432 Miracu MONO 27Gx90mm FDA Feeltech Co.,Ltd. NEW 2026-02-26 28800145524456 Miracu MONO 29Gx40mm FDA Feeltech Co.,Ltd. NEW 2026-02-26 28800145524470 Miracu MONO 29Gx50mm FDA Feeltech Co.,Ltd. NEW 2026-02-26 28800145524487 Miracu MONO 29Gx60mm FDA Feeltech Co.,Ltd. NEW 2026-02-26 30705031470624 PDS ETHICON, LLC NEW 2026-01-29 28800145520687 V-Soft Line BARB STAR 19Gx90mm FDA Feeltech Co.,Ltd. NEW 2026-01-23
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