FDA.report

Trulife

Primary DI
00645517399300
Brand
Trulife
Company
TRULIFE LIMITED
Model
A37-KIT-NIH
Device description
KIT PAD/STRAP NON-INVASIVE HALO
Published
2022-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
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
00645517399300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00645517399300006455173993006455173993000645517399300

GMDN Terms

TermDefinition
Head/neck immobilizer, reusableA 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 reusable device after appropriate cleaning.

Sterilization Methods

Method

Regulatory Flags

DUNS number
289728891
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
true
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

Primary DIBrandModelCatalogPublished
00645517899350TrulifeTN250-22026-02-17
00645517899367TrulifeTN250-32026-02-17
00645517899374TrulifeTN250-42026-02-17
00645517899381TrulifeTN250-52026-02-17
00645517872773TrulifeSSF400-27-L-2 2025-09-19
00645517872780TrulifeSSF400-27-L-3 2025-09-19
00645517872827TrulifeSSF400-28-L-1 2025-09-19
00645517872834TrulifeSSF400-28-L-2 2025-09-19
00645517872872TrulifeSSF400-28-R-3 2025-09-19
00645517872889TrulifeSSF400-29-L-2 2025-09-19
00645517872933TrulifeSSF400-30-R-3 2025-09-19
00645517872988TrulifeSSF403-23-R-1 2025-09-19
00645517873039TrulifeSSF403-24-R-1 2025-09-19
00645517873084TrulifeSSF403-25-L-3 2025-09-19
00645517873138TrulifeSSF403-26-L-2 2025-09-19
00645517873183TrulifeSSF403-27-L-1 2025-09-19
00645517873190TrulifeSSF403-27-L-2 2025-09-19
00645517873237TrulifeSSF403-27-R-3 2025-09-19
00645517873244TrulifeSSF403-28-L-1 2025-09-19
00645517873282TrulifeSSF403-28-R-2 2025-09-19

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