FDA.reportPublic FDA data

AADCO

Primary DI
00840348509328
Brand
AADCO
Company
AADCO MEDICAL, INC.
Model
S-610A
Catalog number
S-610A
Device description
BARRIER ACCESSORY RAIL 8MMX25MM
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
KPYShield, Protective, Personnel

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840348509328PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348509328008403485093288403485093280840348509328

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

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
00191506025625TheraSphere™BOSTON SCIENTIFIC CORPORATIONKPY2026-03-01
00850061871398IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
00850061871404IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
00850061871411IMAGE DIAGNOSTICS, INCIMAGE DIAGNOSTICS, INC.KPY2026-01-30
20748426261905Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
20748426261929Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261932Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
00748426261956Medline-MicrotekMicrotek Medical LLCKPY2026-01-28
05055449412414KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-20
05055449412407KenexKENEX (ELECTRO-MEDICAL) LIMITEDKPY2026-01-07
10748426143075Medline-MicrotekMicrotek Medical LLCKPY2025-09-25
10748426143464DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-25
10748426143440DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426143474DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00748426144273DRAPE ARMOUR™Microtek Medical LLCKPY2025-09-23
00853714008103Steradian ShieldRADUX DEVICES, LLCKPY2025-07-16
30811042030693BLOXRBLOXR Solutions, LLCKPY2025-06-26
10811042030026BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030033BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030040BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030057BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030064BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030071BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030088BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030095BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030101BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030118BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030125BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030132BLOXRBLOXR Solutions, LLCKPY2025-06-25
10811042030149BLOXRBLOXR Solutions, LLCKPY2025-06-25