FDA.reportPublic FDA data

Lumo Spacer, STD-D

Primary DI
04262429650679
Brand
Lumo Spacer, STD-D
Company
macu4 GmbH
Model
03131004
Published
2025-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ISSProsthesis, Thigh Socket, External Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISSProsthesis, Thigh Socket, External ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262429650679PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262429650679042624296506794262429650679

GMDN Terms#

Term, Definition table
TermDefinition
Passive hand prosthesisAn artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to move only as a result of the direct application of external forces.

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
04262429650532Lumo Socket A-1macu4 GmbHISS2026-07-18
04262429650549Lumo Socket A-2macu4 GmbHISS2026-07-18
04262429650556Lumo Socket A-3macu4 GmbHISS2026-07-18
04262429650624Lumo Socket A-4macu4 GmbHISS2026-07-18
04262429650631Lumo Socket B-1macu4 GmbHISS2026-07-18
04262429650891Lumo Socket B-2macu4 GmbHISS2026-07-18
04262429650907Lumo Socket B-3macu4 GmbHISS2026-07-18
04262429650914Lumo Socket B-4macu4 GmbHISS2026-07-18
04262429650921Lumo Socket C-1macu4 GmbHISS2026-07-18
04262429650938Lumo Socket C-2macu4 GmbHISS2026-07-18
04262429650945Lumo Socket C-3macu4 GmbHISS2026-07-18
04262429650952Lumo Socket C-4macu4 GmbHISS2026-07-18
04262429650969Lumo Socket D-1macu4 GmbHISS2026-07-18
04262429650976Lumo Socket D-2macu4 GmbHISS2026-07-18
04262429650983Lumo Socket D-3macu4 GmbHISS2026-07-18
04262429650990Lumo Socket D-4macu4 GmbHISS2026-07-18
04262429651003Lumo Socket E-1macu4 GmbHISS2026-07-18
04262429651010Lumo Socket E-2macu4 GmbHISS2026-07-18
04262429651027Lumo Socket E-3macu4 GmbHISS2026-07-18
04262429651034Lumo Socket F-1macu4 GmbHISS2026-07-18
04262429651041Lumo Socket F-2macu4 GmbHISS2026-07-18
04262429651058Lumo Socket F-3macu4 GmbHISS2026-07-18
04262429651065Lumo Socket F-4macu4 GmbHISS2026-07-18
04262429651072Lumo Socket E-4macu4 GmbHISS2026-07-18
04262429650563Lumo Spacer, STD-Amacu4 GmbHISS2025-11-23
04262429650648Lumo Module Connectormacu4 GmbHISS2025-11-23
04262429650655Lumo Spacer, STD-Bmacu4 GmbHISS2025-11-23
04262429650662Lumo Spacer, STD-Cmacu4 GmbHISS2025-11-23
04262429650686Lumo Spacer, STD-Emacu4 GmbHISS2025-11-23
00713980038023ULTRA SEAL LINERAlps South, LLCISS2025-07-03