Home GUDID 00616784562827 Deluxe Head Immobilizer
Primary DI 00616784562827
Brand Deluxe Head Immobilizer
Company Dynarex Corporation
Model 5628
Device description Deluxe Head Immobilizer, Orange
Published 2021-09-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name MRI Orthosis, Truncal/Orthosis, Limb
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MRI Orthosis, Truncal/Orthosis, Limb Physical Medicine 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00616784562834 Package GS1 5 In Commercial Distribution 00616784562827 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 00616784562834 00616784562834 616784562834 0616784562834 00616784562827 00616784562827 616784562827 0616784562827
GMDN Terms# Term, Definition table Term Definition Extrication collar, single-use A rigid or non-rigid device, usually made of fabric and/or plastic materials, used to temporarily render the head/neck of a patient immovable to ensure immobilization when a head and/or spinal injury is suspected. It is used in conjunction with serious accidents and for transport of the patient on a stretcher and possibly in conjunction with a spinal board to which this device and the patient are strapped. It is typically made of x-ray translucent/non-ferromagnetically active materials that allow x-ray and magnetic resonance imaging (MRI) and comes in various sizes. This is a single-use device.
Regulatory Flags# DUNS number 008124539 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true No natural rubber latex true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 00616784201528 Lab Jackets Knitted Cuffs & Collar with Pockets, X-Large, Blue 2015 2021-09-01 00616784201627 Lab Jackets Knitted Cuffs & Collar with Pockets, 2X-Large, Blue 2016 2021-09-01 00616784206226 Lab Coats Knitted Cuffs & Collar with Pockets, Small, White 2062 2021-09-01
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