FDA.reportPublic FDA data

Adept Medical Overhead Arm Support

Primary DI
09421905187183
Brand
Adept Medical Overhead Arm Support
Company
ADEPT MEDICAL LIMITED
Model
AM2000
Catalog number
AM2000
Device description
Interventional Radiologists have requirement to carry out CT scans of patients for diagnostic and interventional procedures on a patient. This could be on an Angiography Table (Cone Beam CT) or within a CT Scanner (Conventional CT). Minimising X-ray artefact for these procedures is appealing hence the requirement to elevate the patients arms cranially to clear their torso, the region of interest. Interventional Radiologists also have requirement to raise arms clear of the patients torso sides to allow access for biliary drainage procedures.This device aims to facilitate both imaging and patient access application.
Published
2019-01-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421905187183PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421905187183094219051871839421905187183

GMDN Terms#

Term, Definition table
TermDefinition
Radiological arm/leg positionerA device designed to ensure adequate positioning and immobilization of the patient's arms and/or legs during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures. It may include various configurations such as a frame, board, cushion, preformed pad, or shoulder tension rope, strap, or handle grip that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
592534619
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421901970345NeoZolineNZ3306NZ33062016-02-25
09421901970352NeoZolineNZ3306-2NZ3306-22016-02-25
09421901970369NeoZolineNZ3309NZ33092016-02-25
09421901970376NeoZolineNZ3309-2NZ3309-22016-02-25
09421901970383NeoZolineNZ3312NZ33122016-02-25
09421901970390NeoZolineNZ3312-2NZ3312-22016-02-25
09421901970406NeoZolineNZ3321NZ33212016-02-25
09421901970413NeoZolineNZ3321-2NZ3321-22016-02-25
09421905187770Adept Medical Retrograde IR Platform - Narrow + ExtensionAM0460AM04602026-02-09
09421905187787Adept Medical IR Platform Extension - NarrowAM0470AM04702026-02-09
09421902825927Arm StrapsAM0620AM06202018-05-24
09421902825491Adept Medical Femoral TableAM0300AM03002017-05-29
09421902825880IR ShieldAM0500AM05002017-11-24
09421902825941Adept Medical Drape SupportAM1000AM10002018-07-25
09421905187374Adept Medical ArmSureAM0640AM06402024-03-20
09421905187435Adept Medical STARTableDAM0140D2024-02-15
09421905187558Adept Medical Arm Support PadAAM01712022-10-13
09421905187589Adept Medical Drape SupportBAM1000B2022-10-13
09421902825712Adept Medical STARTableAM0140CAM0140C2017-05-29
09421902825934Arm Sure ShieldAM0630AM06302018-05-24

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