Home GUDID 00190446339465 DONJOY ADVANTAGE
Primary DI 00190446339465
Brand DONJOY ADVANTAGE
Company DJO, LLC
Model DA161FB01-BLK-L,XL
Device description DJA PLANTAR FASCIITIS NIGHT SPLINT, BLACK, LARGE/XLARGE
Published 2022-05-19
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 false 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 00190446339465 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 00190446339465 00190446339465 190446339465 0190446339465
GMDN Terms# Term, Definition table Term Definition Ankle/foot orthosis An externally-applied appliance or apparatus intended to encompass the ankle joint, or the ankle and foot, to support, align, prevent, or correct orthopaedic deformities/injuries or to improve function of the ankle and/or foot through actions such as alignment, hinge-support, or dorsiflexion assistance. It may also be intended to offload and redistribute foot pressures that affect pedal circulation to improve blood flow and help heal diabetic foot ulcers or postsurgical wounds, and may include customizable plantar inserts. This is a single-patient device that can be reapplied to the patient during the treatment period (reusable) before being discarded.
Regulatory Flags# DUNS number 081840873 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number false Manufacturing date on label false 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