Home GUDID 00810003753748 KENTEX
Primary DI 00810003753748
Brand KENTEX
Company KENTRON HEALTHCARE, INC.
Model 826026
Device description CARDBOARD SPLINT 24" WITH THREE PIECE FOAM
Published 2024-02-19
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC true
Sterile 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 00810003753748 Package GS1 36 In Commercial Distribution 00810003753731 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 00810003753748 00810003753748 810003753748 0810003753748 00810003753731 00810003753731 810003753731 0810003753731
GMDN Terms# Term, Definition table Term Definition General-purpose medical foam padding, single-use A roll, sheet or preformed shape of synthetic latex 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 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 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 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