FDA.reportPublic FDA data

ComfortLite

Primary DI
00840348528619
Brand
ComfortLite
Company
AADCO MEDICAL, INC.
Model
LP-C802LMC
Catalog number
LP-C802LMC
Device description
MAGNALATCH COMFORTLITE THYROID FLARE CUSTOM
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
EAJApron, Leaded

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAJApron, LeadedRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840348528619PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348528619008403485286198403485286190840348528619

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding collarA personal protective device intended to shield the neck area including the nape, the throat, and the thyroid of an individual (i.e., a device operator or other attending person) from unnecessary exposure to radiation during diagnostic or therapeutic medical and dental procedures. Collars used in x-ray and nuclear medicine typically consist of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Collars used for neutron attenuation are composed of hydrogenous materials instead of lead; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

Regulatory Flags#

DUNS number
153603204
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840348507690AADCOPB-505PB-5052022-12-14
00840348526493AADCON-640N-6402022-12-16
00840348526509AADCON-640DN-640D2022-12-16
00840348507409AADCOPB-200PB-2002022-12-07
00840348507416AADCOPB-201PB-2012022-12-07
00840348507454AADCOPB-206PB-2062022-12-07
00840348507461AADCOPB-207PB-2072022-12-07
00840348524185AADCOP-302P-3022022-12-07
00840348524192AADCOP-303P-3032022-12-07
00840348524208AADCOP-305P-3052022-12-07
00840348506396AADCOP-610P-6102022-12-14
00840348506402AADCOP-610CSP-610CS2022-12-14
00840348506419AADCOP-611P-6112022-12-14
00840348506426AADCOP-611CSP-611CS2022-12-14
00840348507997AADCOPBS-025PBS-0252022-12-14
00840348506259AADCOP-306P-3062022-12-07
00840348506709AADCOPB-121PB-1212022-12-07
00840348506716AADCOPB-121CPB-121C2022-12-07
00840348506723AADCOPB-122PB-1222022-12-07
00840348506730AADCOPB-122CPB-122C2022-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G031VBO2XFNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XFTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBO2XMTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLFTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOLMTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFNLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFRL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFRLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFTL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMFTLL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13
G031VBOMMNL0Vest Only w/ BeltShielding International Inc.EAJ2026-07-13