FDA.reportPublic FDA data

Optos Arm Rest

Primary DI
05057056108049
Brand
Optos Arm Rest
Company
OPTOS PUBLIC LIMITED COMPANY
Model
A10804
Catalog number
A10804
Published
2022-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IMLArmrest, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMLArmrest, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05057056108049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05057056108049050570561080495057056108049

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.

Contacts#

Phone, Email table
PhoneEmail
+441383843300eroome@optos.com

Regulatory Flags#

DUNS number
346013337
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05057056003856Optos OCT/SLOOCT0003852016-11-23
05057056010212Panoramic OphthalmoscopeP200A10212016-05-27
05057056100210Panoramic OphthalmoscopeP200CA100212016-05-27
05057056100920Panoramic Opthalmoscope200TxA100922016-11-23
05057056106007Panoramic OphthalmoscopeP200TA106002016-05-27
05057056106397OPTOS ADVANCE IMAGE SERVERA106392016-05-27
05057056106502Panoramic OphthalmoscopeP200DTxA106502016-05-27
05057056106885OPTOS ADVANCE IMAGE SERVERA106882016-05-27
05057056107004OCT OphthalmoscopeP200TEA107002018-04-02
05057056905709OPTOS ADVANCES905702016-05-27
05057056107509OCT Ophthalmoscope P200TxEA107502019-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841447115854Freedom Designs™ Recover Armrest PadsINVACARE CORPORATIONIML2025-10-27
00841447115861Freedom Designs™ Armrest Pads OnlyINVACARE CORPORATIONIML2025-10-27
00841447115922Freedom Designs™ Arm Trough with T-NutsINVACARE CORPORATIONIML2025-10-27
00841447115939Freedom Designs™ Arm Trough with Multi Axial HardwareINVACARE CORPORATIONIML2025-10-27
00815067013319ProbasicsDrive Devilbiss HealthcareIML2025-06-10
00197344014623MEDLINEMEDLINE INDUSTRIES, INC.IML2025-05-07
10197344033485MEDLINEMEDLINE INDUSTRIES, INC.IML2025-04-05
80197344033484MEDLINEMEDLINE INDUSTRIES, INC.IML2025-04-05
10193489188127MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489188134MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489188141MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489188165MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
00197344014555MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80197344014551MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188126MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188133MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188140MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
80193489188164MEDLINEMEDLINE INDUSTRIES, INC.IML2025-03-10
10193489187939MEDLINEMEDLINE INDUSTRIES, INC.IML2024-12-20
10193489187953MEDLINEMEDLINE INDUSTRIES, INC.IML2024-12-20
10193489187960MEDLINEMEDLINE INDUSTRIES, INC.IML2024-12-20
00810113576909Vive MobilityVIVE HEALTH LLCIML2024-09-04
10810113576906Vive MobilityVIVE HEALTH LLCIML2024-09-04
00841447114949KIT ARMPAD FULL W/2 SCREWS CLRINVACARE CORPORATIONIML2024-07-25
00841447114956KIT ARMPAD DESK W/2 SCREWS CLRINVACARE CORPORATIONIML2024-07-25
10197344033478MEDLINEMEDLINE INDUSTRIES, INC.IML2024-06-20
00197344014562MedlineMEDLINE INDUSTRIES, INC.IML2024-04-11
00197344014647GuardianMEDLINE INDUSTRIES, INC.IML2024-03-05
10193489188264MedlineMEDLINE INDUSTRIES, INC.IML2024-01-16
20193489188261MedlineMEDLINE INDUSTRIES, INC.IML2024-01-16