Home GUDID 00616784353319 ActiSplint with Sensi-Wrap
Primary DI 00616784353319
Brand ActiSplint with Sensi-Wrap
Company DYNAREX CORPORATION
Model 3533
Device description ActiSplint with Sensi-Wrap 2"x5yds, Red/Charcoal Gray Rolled Splint, Black Self-Adherent Bandage, 36" ActiSplint, 2"x5 Sensi Wrap; Combo Packs
Published 2021-09-01
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 00616784353333 Primary GS1 0 00616784353319 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00616784353333 00616784353333 616784353333 0616784353333 00616784353319 00616784353319 616784353319 0616784353319
GMDN Terms# Term, Definition table Term Definition Arm splint system, self-moulding A collection of non-sterile devices designed to produce a moulded splint that is formed around the upper limb of a patient who requires support or immobilization (e.g., to treat fractures, injuries, strains, sprains). It typically consists of a two-component polyurethane that is mixed and poured into a textile which matches this part of the body creating a rigid or soft foam splint that is applied to the patient’s arm where it sets. It is available in different sizes. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Regulatory Flags# DUNS number 008124539 Device count 50 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 true Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00840117320987 Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc Canister 32409 2026-09-25 00840117352735 dmecare Solutions Folding Beside Commode 10370 2021-04-22 00840117352742 dmecare Solutions Elongated Folding Bedside Commode 10371 2021-04-22 00840117308855 Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL 34221 2022-05-11 00616784431321 Junior Tongue Depressors, 5 1/2" (14.0 cm) 4313 2021-09-01 00616784431420 Senior Tongue Depressors, 6" (15.2 cm) 4314 2021-09-01 00616784435213 Gait Belt, Natural Colors, Metal Buckle, 60" x 2" 4352 2021-09-01 00616784435312 Gait Belt, Multicolor, Metal Buckle, 60" x 2" 4353 2021-09-01 00616784435411 Gait Belt, Multicolor, Wipeable Plastic Buckle, 60" x 2" 4354 2021-09-01 00616784351612 Heavy Duty Fitted Cot Sheet, White, 30" x 73" 3516 2021-09-01 00616784351711 Premium Flat Cot Sheet, Dark Blue, 40" x 85" 3517 2021-09-01 00616784368115 Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56" 3681 2021-09-01 00616784369228 Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd 3692 2021-09-01 00616784369327 Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd 3693 2021-09-01 00616784369426 Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd 3694 2021-09-01 00616784369624 Cotton Stockinette 3696 2021-09-01 00840117349841 IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm) 7055 2026-06-30 00616784201221 Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue 2012 2021-09-01 00616784201320 Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue 2013 2021-09-01 00616784201429 Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue 2014 2021-09-01
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