FDA.reportPublic FDA data

AADCO

Primary DI
00840348509359
Brand
AADCO
Company
AADCO MEDICAL, INC.
Model
S-620
Catalog number
S-620
Device description
Upright Interventional X-ray Barrier 0.5mm
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
00840348509359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348509359008403485093598403485093590840348509359

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00840348529333ErgoLiteLP-EX708LP-EX7082025-02-05
00840348529326AADCOOSP-755OSP-7552025-01-22
00840348529319AADCOPS-311APS-311A2024-11-13
00840348529302AADCOPS-405SPS-405S2024-10-21
00840348529296AADCOOSP-260NFOSP-260NF2024-10-15
00840348529289ComfortLiteLP-CL800XALP-CL800XA2024-09-09
00840348526233AADCON-101N-1012022-12-15
00840348525694AADCODB-1922CF100DB-1922CF1002022-12-19
00840348525700AADCODB-1922CF1KDB-1922CF1K2022-12-19
00840348525762AADCODB-2620NDB-2620N2022-12-19
00840348525779AADCODB-2820NDB-2820N2022-12-19
00840348526806MRI-SafeNF-500NF-5002022-12-19

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
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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