FDA.report

Deluxe Head Immobilizer

Primary DI
00616784562834
Brand
Deluxe Head Immobilizer
Company
DYNAREX CORPORATION
Model
5628
Device description
Deluxe Head Immobilizer, Orange
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
true

Related Records

Product Codes

CodeName
MRIOrthosis, Truncal/Orthosis, Limb

Product Code Classifications

CodeDeviceSpecialtyClass
MRIOrthosis, Truncal/Orthosis, LimbPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00616784562834PackageGS15In Commercial Distribution
00616784562827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784562834006167845628346167845628340616784562834
00616784562827006167845628276167845628270616784562827

GMDN Terms

TermDefinition
Head/neck immobilizer, single-useA rigid or non-rigid, non-sterile, 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
008124539
Device count
1
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

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