FDA.reportPublic FDA data

Armboard turnable

Primary DI
07350111830601
Brand
Armboard turnable
Company
Reison Medical AB
Model
10-387-AUSTRALIA
Published
2022-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LGXTable, Examination, Medical, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07350111830601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07350111830601073501118306017350111830601

GMDN Terms#

Term, Definition table
TermDefinition
Arm procedure positioner, reusableA preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
356766220
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07350111831103Head rest10-2302022-04-30
07350111831110Head rest10-230-B2022-04-30
07350111831127Head rest10-230-F2022-04-30
07350111831134Head rest10-230-Fdbl2022-04-30
07350111831141Head rest10-230-Mdbl2022-04-30
07350111831158Head rest10-230-NO2022-04-30
07350111831165Head rest10-230-PED2022-04-30
07350111831172Head rest10-230-Steris2022-04-30
07350111831189Head rest10-230-T2022-04-30
07350111831196Head rest10-230-Tdbl2022-04-30
07350111831219Head rest10-2312022-04-30
07350111831226Head rest10-231-T2022-04-30
07350111831233Head rest10-2322022-04-30
07350111831240Head rest10-2332022-04-30
07350111831257Head rest10-2342022-04-30
07350111831264Head rest10-234-T2022-04-30
07350111831271Head rest10-235-MK22022-04-30
07350111831288Head rest10-2372022-04-30
07350111831295Head rest10-237-Mayf2022-04-30
07350111831301Head rest10-237-T2022-04-30

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00848871001531EchoBedMEDICAL POSITIONING, INC.LGX2026-04-20
00670482001071Echo-Flex 5002Umano Medical IncLGX2026-02-18
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