FDA.reportPublic FDA data

ErgoLite

Primary DI
00840348519938
Brand
ErgoLite
Company
AADCO MEDICAL, INC.
Model
LP-EA451
Catalog number
LP-EA451
Device description
.35MM ERGOLITE MAGNABACK VEST SMALL FEMALE BLUE
Published
2022-12-07
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
00840348519938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348519938008403485199388403485199380840348519938

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding apronA full or half-length apron-like garment intended to shield portions of the body of an individual (i.e., a device operator, patient, or other attending person) from exposure to radiation during medical or dental procedures. Some include attached or detachable collars for neck and thyroid protection. The device typically consists of a fluid resistant outer covering surrounding a thin sheet of lead (Pb) or lead-equivalent material. Those used for neutron attenuation are composed of hydrogenous materials; those used in mixed beta-gamma radiation field may have layers of both hydrogenous and lead-equivalent materials. This is a reusable device.

Sterilization Methods#

Method table
Method

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
G031QRSOMFRL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOMMNL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOMMRL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOMMRLL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOMMTL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSFNL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSFRL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSFRLL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSFTL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSMNL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSMTL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-28
G031QRSOSMRLL0Quick Release Skirt OnlyShielding International Inc.EAJ2026-04-22
G031SO2XFRL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XFRLL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XFTL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XMNL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XMRL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XMRLL0SkirtShielding International Inc.EAJ2026-04-22
G031SO2XMTL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLFNL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLFRL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLFRLL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLFTL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLMNL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLMRL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLMRLL0SkirtShielding International Inc.EAJ2026-04-22
G031SOLMTL0SkirtShielding International Inc.EAJ2026-04-22
G031SOMFNL0SkirtShielding International Inc.EAJ2026-04-22
G031SOMFRL0SkirtShielding International Inc.EAJ2026-04-22
G031SOMFRLL0SkirtShielding International Inc.EAJ2026-04-22