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 00840117305274 Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500 30101 2021-04-22 00840117305298 Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1000 30103 2021-04-22 00840117305656 Resp-O2 Heat Moisture Exchanger + B/V Filter (HMEF) 1500 30100 2021-04-22 00840117305847 Resp-O2 Heat Moisture Exchanger + Filter (HMEF) 1500 30102 2021-04-22 00840117307728 Ever-Soft Positioning Wedge 13001 2021-04-22 00840117307742 Ever-Soft Positioning Wedge 13002 2021-04-22 00840117307766 Ever-Soft Positioning Wedge 13003 2021-04-22 00840117321045 Bari+Max Bariatric Gel Foam Wheelchair Cushion 24"x18"x3" 13054 2021-04-22 00840117321052 Bari+Max Bariatric Gel Foam Wheelchair Cushion 26"x20" "x3" 13055 2021-04-22 00840117321090 Bari+Max Bariatric Gel/Foam Cushion 22"x18"x3" 13050 2021-04-22 00840117321106 Bari+Max Bariatric Gel/Foam Cushion 24"x18"x3" 13051 2021-04-22 00616784304113 Dmecare Solutions Solid Seat Insert 13041-16 2021-09-01 00616784304212 DMECare Solutions Solid Seat Insert 13041-18 2021-09-01 00616784304311 DMECare Solutions Solid Seat Insert 13041-20 2021-09-01 00616784304410 DMECare Solutions Solid Seat Insert 13041-22 2021-09-01 00616784304519 DMECare Solutions Solid Seat Insert 13041-24 2021-09-01 00840117321021 Bariatric Reclining Wheelchair 24" with Elevating Leg Rest 15015-24DELR 2024-05-08 00840117321168 DynaRide Pediatric Wheelchair with Footrest 12" 15009-12DFR 2024-05-09 00840117321175 DynaRide Pediatric Wheelchair with Footrest 14" 15009-14DFR 2024-05-09 00840117322684 Bariatric Reclining Wheelchair 26" with Elevating Leg Rest 15015-26DELR 2024-05-08
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