FDA.report

AADCO

Primary DI
00840348526486
Brand
AADCO
Company
AADCO MEDICAL, INC.
Model
N-630
Catalog number
N-630
Device description
DECUBI-POSITIONER STD.
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

Related Records

Product Codes

CodeName
LWGSurgical Table Cushion

Product Code Classifications

CodeDeviceSpecialtyClass
LWGSurgical Table CushionGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840348526486PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840348526486008403485264868403485264860840348526486

GMDN Terms

TermDefinition
Radiological general body-part positionerA device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods

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 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

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