Home GUDID 08809818038128 Guardian Splint
Primary DI 08809818038128
Brand Guardian Splint
Company BM KOREA CO., LTD
Model GLLC
Device description This product is made by molding thermoplastic synthetic resin to the affected area, and is used to support and immobilize the joint and surrounding areas.
Published 2025-03-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information 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 08809818038128 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809818038128 08809818038128 8809818038128
GMDN Terms# Term, Definition table Term Definition First aid limb splint, non-mouldable, reusable A portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It consists of an unpadded, non-mouldable rigid portion which is applied externally to the limb and held in place with straps/ropes, and may be capable or applying traction; it is made of a variety of materials, and may be used in the home or by emergency medical services (EMS). This is a reusable device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 430 Millimeter Width 125 Millimeter
Regulatory Flags# DUNS number 557799209 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