Home GUDID 00810003753892 KENAFLEXX
Primary DI 00810003753892
Brand KENAFLEXX
Company KENTRON HEALTHCARE, INC.
Model 885515
Device description "PADDED BOARD SPLINT 15"" ORANGE"
Published 2024-02-19
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
OTC true
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 00810003753908 Package GS1 50 In Commercial Distribution 00810003753892 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 00810003753908 00810003753908 810003753908 0810003753908 00810003753892 00810003753892 810003753892 0810003753892
GMDN Terms# Term, Definition table Term Definition General-purpose medical foam padding, single-use A roll, sheet or preformed shape of synthetic foam material [e.g., styrene-butadiene rubber (SBR)] intended to be applied to and/or compress a local area of the body for various preventative/therapeutic applications (e.g., in compression bandaging, padding under casts and splints, padding for anatomical depressions), typically over intact and healthy skin. It is intended for use in the home or a clinical setting. This is a single-use device.
Regulatory Flags# DUNS number 618825723 Device count 1 Premarket exempt true Lot or batch 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 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 00609271040076 Body Armor® Stirrup Walker DARCO INTERNATIONAL, INC. NOC 2023-09-22