FDA.reportPublic FDA data

Lumo Socket F-1

Primary DI
04262429651034
Brand
Lumo Socket F-1
Company
macu4 GmbH
Model
v1.0
Catalog number
03171001x
Published
2026-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

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
04262429651034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262429651034042624296510344262429651034

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
04262429651041Lumo Socket F-2v1.003171002x2026-07-18

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
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
04262429650679Lumo Spacer, STD-Dmacu4 GmbHISS2025-11-23
04262429650686Lumo Spacer, STD-Emacu4 GmbHISS2025-11-23
00713980038023ULTRA SEAL LINERAlps South, LLCISS2025-07-03