Home GUDID 00609271031357 DARCO® GTS™ Great Toe Splint
Primary DI 00609271031357
Brand DARCO® GTS™ Great Toe Splint
Company DARCO INTERNATIONAL, INC.
Model GTS2L
Catalog number GTS2L
Device description Large/Extra-large Black Left
Published 2023-02-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name NOC Splint, extremity, non-inflatable, external, non-sterile
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NOC Splint, Extremity, Non-Inflatable, External, Non-Sterile General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 20609271031351 Package GS1 12 In Commercial Distribution 00609271031357 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 20609271031351 20609271031351 00609271031357 00609271031357 609271031357 0609271031357
GMDN Terms# Term, Definition table Term Definition Toe separator A foot-worn device designed to space the toes of the foot to relieve pain, pressure/friction between toes, and/or to facilitate realignment of the toes to a natural position. It is made of soft materials (e.g., silicone, polymer gel) and may be available in a variety of forms (e.g., circular channels moulded together, small disks, half moon shape); some types are in addition intended to protect and/or reduce bunion or Tailor’s bunion formation. This is a reusable device.
Regulatory Flags# DUNS number 184231298 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810003753694 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753717 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753731 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753755 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753854 KENAFLEXX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753878 KENAFLEXX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753892 KENAFLEXX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753915 KENAFLEXX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753533 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753557 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753571 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753595 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753618 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753632 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753656 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753670 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753779 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753793 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753816 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753830 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00609271040021 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-11-02 00609271040038 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-11-02 00609271040045 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-11-02 00609271040229 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-11-02 00609271040236 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-11-02 00609271040243 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-11-02 00609271040007 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-09-22 00609271040014 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-09-22 00609271040052 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-09-22 00609271040069 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-09-22