FDA.reportPublic FDA data

AADCO

Primary DI
00840348509397
Brand
AADCO
Company
AADCO MEDICAL, INC.
Model
S-625P
Catalog number
S-625P
Device description
INTENSI-BARRIER 12" W X 16" H
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
00840348509397PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348509397008403485093978403485093970840348509397

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
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
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