Home GUDID 20609271243006 DARCO® Relief Insert™
Primary DI 20609271243006
Brand DARCO® Relief Insert™
Company DARCO INTERNATIONAL, INC.
Model RI-1
Catalog number RI-1
Device description S Grey Shell
Published 2023-02-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
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 20609271243006 Package GS1 12 In Commercial Distribution 00609271243002 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 20609271243006 20609271243006 00609271243002 00609271243002 609271243002 0609271243002
GMDN Terms# Term, Definition table Term Definition Orthotic shoe, non-customized A prefabricated (non-customized) footwear designed as a shoe intended to support, align, prevent, and compensate for or correct deformities of the feet to help improve function and/or for post-operative therapy. This is a reusable device.
Regulatory Flags# DUNS number 184231298 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label false 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 00190446683407 PROCARE DJO, LLC NOC 2025-07-08 00190446683414 PROCARE DJO, LLC NOC 2025-07-08 00190446662754 PROCARE DJO, LLC NOC 2025-07-07 00190446662761 PROCARE DJO, LLC NOC 2025-07-07 00190446662778 PROCARE DJO, LLC NOC 2025-07-07 14251853902826 Body Armor® PFA Walker Darco (Europe) GmbH NOC 2025-04-15 14251853902833 Body Armor® PFA Walker Darco (Europe) GmbH NOC 2025-04-15 14251853902840 Body Armor® PFA Walker Darco (Europe) GmbH NOC 2025-04-15 08809818038111 Guardian Splint BM KOREA CO., LTD NOC 2025-03-20 08809818038128 Guardian Splint BM KOREA CO., LTD NOC 2025-03-20 08809818038135 Guardian Splint BM KOREA CO., LTD NOC 2025-03-20 08809818038142 Guardian Splint BM KOREA CO., LTD NOC 2025-03-20 08809818038159 Guardian Splint BM KOREA CO., LTD NOC 2025-03-20 08809818038166 Guardian Splint BM KOREA CO., LTD NOC 2025-03-20 06977071937501 Meicen Guangdong Meicen Medical Equipment Co., Ltd. NOC 2024-06-21 00810003753700 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753724 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753748 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753762 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753861 KENAFLEXX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753885 KENAFLEXX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753908 KENAFLEXX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753922 KENAFLEXX KENTRON HEALTHCARE, INC. NOC 2024-02-19 00810003753540 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753564 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753588 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753601 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753625 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753649 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18 00810003753663 KENTEX KENTRON HEALTHCARE, INC. NOC 2024-02-18