Home GUDID 08809818038135 Guardian Splint
Primary DI 08809818038135
Brand Guardian Splint
Company BM KOREA CO., LTD
Model GSL-S
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 08809818038135 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08809818038135 08809818038135 8809818038135
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 300 Millimeter Width 100 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