FDA.reportPublic FDA data

Lumo Cuff, STD-SML-D

Primary DI
04262429650518
Brand
Lumo Cuff, STD-SML-D
Company
macu4 GmbH
Model
03011004
Published
2025-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ILTAdaptor, Recreational

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILTAdaptor, RecreationalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262429650518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262429650518042624296505184262429650518

GMDN Terms#

Term, Definition table
TermDefinition
Wrist/hand orthosisAn externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.

Regulatory Flags#

DUNS number
344157954
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
04262429650532Lumo Socket A-1v1.003081001x2026-07-18
04262429650549Lumo Socket A-2v1.003081002x2026-07-18
04262429650556Lumo Socket A-3v1.003081003x2026-07-18
04262429650624Lumo Socket A-4v1.003081004x2026-07-18
04262429650631Lumo Socket B-1v1.003091001x2026-07-18
04262429650891Lumo Socket B-2v1.003091002x2026-07-18
04262429650907Lumo Socket B-3v1.003091003x2026-07-18
04262429650914Lumo Socket B-4v1.003091004x2026-07-18
04262429650921Lumo Socket C-1v1.003101001x2026-07-18
04262429650938Lumo Socket C-2v1.003101002x2026-07-18
04262429650945Lumo Socket C-3v1.003101003x2026-07-18
04262429650952Lumo Socket C-4v1.003101004x2026-07-18
04262429650969Lumo Socket D-1v1.003111001x2026-07-18
04262429650976Lumo Socket D-2v1.003111002x2026-07-18
04262429650983Lumo Socket D-3v1.003111003x2026-07-18
04262429650990Lumo Socket D-4v1.003111004x2026-07-18
04262429651003Lumo Socket E-1v1.003121001x2026-07-18
04262429651010Lumo Socket E-2v1.003121002x2026-07-18
04262429651027Lumo Socket E-3v1.003121003x2026-07-18
04262429651034Lumo Socket F-1v1.003171001x2026-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429651096Lumo Hold O-2macu4 GmbHILT2026-07-18
04262429651102Lynk Hold Lock O-2macu4 GmbHILT2026-07-18
04262429650204Lynk Hook Module standardmacu4 GmbHILT2025-11-23
04262429650211Lynk Push Module standardmacu4 GmbHILT2025-11-23
04262429650228Lynk Hold STD Modulemacu4 GmbHILT2025-11-23
04262429650235Lynk Clic Modulemacu4 GmbHILT2025-11-23
04262429650242Lynk Clic Head 360°macu4 GmbHILT2025-11-23
04262429650259Lynk Clic Head 70°macu4 GmbHILT2025-11-23
04262429650266Lynk Clic Head 0°macu4 GmbHILT2025-11-23
04262429650273Lynk Clic Adaptermacu4 GmbHILT2025-11-23
04262429650327Lynk Clic Lock Modulemacu4 GmbHILT2025-11-23
04262429650334Lynk Clic Lock Head 360°, STDmacu4 GmbHILT2025-11-23
04262429650341Lynk Clic Lock Head 70°, STDmacu4 GmbHILT2025-11-23
04262429650358Lynk Clic Lock Head 0°, STDmacu4 GmbHILT2025-11-23
04262429650365Lynk Clic Lock Adaptermacu4 GmbHILT2025-11-23
04262429650372Lynk Hold Lock Modulemacu4 GmbHILT2025-11-23
04262429650389Lumo Cuff, STD-SML-Amacu4 GmbHILT2025-11-23
04262429650396Lumo Shovel, STDmacu4 GmbHILT2025-11-23
04262429650402Lumo Hold, Lockmacu4 GmbHILT2025-11-23
04262429650419Lumo Roll, STDmacu4 GmbHILT2025-11-23
04262429650426Lumo Clamp, STDmacu4 GmbHILT2025-11-23
04262429650433Lynk Clic Lock Head 70°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650440Lynk Clic Lock Head 0°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650457Lynk Clic Lock Head 360°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650464Lynk Clic Lock Head 70°, FLATmacu4 GmbHILT2025-11-23
04262429650471Lynk Clic Lock Head 360°, FLATmacu4 GmbHILT2025-11-23
04262429650488Lynk Clic Lock Head 0°, FLATmacu4 GmbHILT2025-11-23
04262429650495Lumo Cuff, STD-SML-Bmacu4 GmbHILT2025-11-23
04262429650501Lumo Cuff, STD-SML-Cmacu4 GmbHILT2025-11-23
04262429650525Lumo Cuff, STD-SML-Emacu4 GmbHILT2025-11-23