FDA.reportPublic FDA data

Collim-Aid

Primary DI
00860001700107
Brand
Collim-Aid
Company
Reina Imaging
Model
CA2
Device description
The Collim-Aid fits onto the collimator, shielding the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPYShield, Protective, Personnel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPYShield, Protective, PersonnelRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001700107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001700107008600017001078600017001070860001700107

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, portable/mobileA portable or mobile rigid barrier designed to shield patients and healthcare professionals from unnecessary exposure to radiation used in diagnostic or therapeutic medical procedures. It provides a physical radiation-attenuating barrier between an individual and a source of primary or scattered radiation. It may be a stand-alone device or intended to be integrated within an electronic system; the panel itself is not electronic. The types of materials used depend on the type of radiation to be attenuated [e.g., those used in diagnostic x-ray and nuclear medicine consist of lead (Pb) or lead-equivalent materials, and those used to attenuate neutrons are composed of hydrogenous materials].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8153568181treina@reinaimaging.com

Regulatory Flags#

DUNS number
102370137
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860001700169Stitching Platform with Handles/ Clear Stitching StandCSS[X]; SPH-F2023-06-08
00860001700176Weight Bearing DRP HoldersWDDR[X]2023-06-08
00860001700121Trans-Former[T][#]-[Z]Digital Detector Holder2019-10-29
00860001700183Protect-A-GridP[2][X]DR[NG][Y]Premium Grid Encasement 2019-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850061871237IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
00850061871459IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-02-24
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00816611026052Halyard Scatter Radiation ShieldsANGIOSYSTEMS, INCORPORATEDKPY2025-01-30
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