FDA.reportPublic FDA data

AADCO

Primary DI
00840348527513
Brand
AADCO
Company
AADCO MEDICAL, INC.
Model
SC-731
Catalog number
SC-731
Device description
"32""X40"" 1.5MM (35MM) 1.5MM CLEAR LEAD ACRYLIC "
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EAKScreen, Leaded, Operator Radiation Protector

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAKScreen, Leaded, Operator Radiation ProtectorRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840348527513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348527513008403485275138403485275130840348527513

GMDN Terms#

Term, Definition table
TermDefinition
Radiation shielding panel, fixedA permanently installed device forming a structural barrier designed to block or attenuate radiation emissions from a primary or scattered radiation source. It includes various solid or transparent barriers typically used to shield patients from unnecessary exposure to radiation emitted from, e.g., diagnostic/therapeutic radiation emitting devices. It may also be used to shield a patient undergoing a diagnostic or therapeutic procedure requiring the administration of a radioactive material or placement of a radioactive source. The barrier can be permanently attached to the floor, wall or ceiling or to a medical device, or mounted on articulating structures giving a limited range of motion.

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
00860010101285Rampart Head ShieldRampart Ic, LLCEAK2026-04-27
04251339907669OTMAVIG GmbHEAK2026-04-14
04251339906822OTMAVIG GmbHEAK2026-02-12
04251339907263OTMAVIG GmbHEAK2026-02-12
04251339907270OTMAVIG GmbHEAK2026-02-12
04251339907287OTMAVIG GmbHEAK2026-02-12
04251339907294OTMAVIG GmbHEAK2026-02-12
04251339907409OTMAVIG GmbHEAK2026-02-12
05055449412438KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2026-02-09
05055449412285KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2025-09-10
00860010101230Sentry Radiation ShieldRampart Ic, LLCEAK2025-08-29
00860010101254Liberty Floor StandRampart Ic, LLCEAK2025-08-08
05055449409933KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2025-06-09
05055449412223KenexKENEX (ELECTRO-MEDICAL) LIMITEDEAK2025-06-06
G242MB2430G209Techno-AideTechno-Aide, Inc.EAK2025-05-05
G242MB3060G209Techno-AideTechno-Aide, Inc.EAK2025-05-05
G242MB2430G2090Techno-AideTechno-Aide, Inc.EAK2025-05-05
G242MB3060G2090Techno-AideTechno-Aide, Inc.EAK2025-05-05
00860010101209Defender Radiation ShieldRampart Ic, LLCEAK2025-04-07
00860010101247Guardian Radiation ShieldRampart Ic, LLCEAK2025-04-07
00850067930020EggNestEGG Medical, Inc.EAK2025-03-16
05055449412018KENEXKENEX (ELECTRO-MEDICAL) LIMITEDEAK2024-12-09
04251339906280OTMAVIG GmbHEAK2024-06-03
04251339906297OTMAVIG GmbHEAK2024-06-03
04251339906006OTMAVIG GmbHEAK2024-04-19
04251339906013OTMAVIG GmbHEAK2024-04-19
00860002090108Rampart Rampart Ic, LLCEAK2023-08-25
00860002090177Rampart Rampart Ic, LLCEAK2023-08-25
00860002090184RampartRampart Ic, LLCEAK2023-08-25
00860002090191Rampart Rampart Ic, LLCEAK2023-08-25