FDA.reportPublic FDA data

MRI-Safe

Primary DI
00840348505450
Brand
MRI-Safe
Company
AADCO MEDICAL, INC.
Model
OSPL-202HNF
Catalog number
OSPL-202HNF
Device description
MRI SAFE DUAL MONITOR MOUNT HORIZONTAL FOR INTERNAL WIRING
Published
2022-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWEMonitor, Patient Position, Light-Beam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWEMonitor, Patient Position, Light-BeamRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840348505450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348505450008403485054508403485054500840348505450

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made medical device mountA structure intended to be permanently-fixed to the ceiling and/or wall to support/stow a medical device(s) [e.g., light, monitor, surgical instruments] or stow/provide medical supplies. It is designed with specific characteristics as requested by a healthcare professional to meet the requirements of a specific facility. It may incorporate a pole, rack, shelves, electricity supply sockets, gas outlets, and/or enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device(s) to be mounted is not included.

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
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06977071931295MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931301MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931318MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
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06977071931332MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
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06977071931356MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
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06977071931400MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
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06977071931493MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931509MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931516MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
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06977071931585MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
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06977071931608MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931615MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931622MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931639MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26
06977071931646MeicenGuangdong Meicen Medical Equipment Co., Ltd.IWE2026-06-26