FDA.reportPublic FDA data

Lumo Spacer, STD-B

Primary DI
04262429650655
Brand
Lumo Spacer, STD-B
Company
macu4 GmbH
Model
03131002
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
04262429650655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262429650655042624296506554262429650655

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
04262429650884Explorer Hold Lock Modulev1.00115(1 2)0002026-03-23
04262429650006Explorer Bike Module STD without spacer0102(1/2)0002025-11-23
04262429650013Explorer Bike Module STD with spacer0102(1/2)xxx2025-11-23
04262429650020Explorer Ball Module STD without spacer0103(1/2)0002025-11-23
04262429650037Explorer Ball Module STD with spacer0103(1/2)xxx2025-11-23
04262429650044Explorer Ball Module SML without spacer0103(3/4)0002025-11-23
04262429650051Explorer Ball Module SML with spacer0103(3/4)xxx2025-11-23
04262429650068Explorer Swim Module STD without spacer0104(1/2)0002025-11-23
04262429650075Explorer Swim Module SML without spacer0104(3/4)0002025-11-23
04262429650082Explorer Twin Module STD without spacer0105(1/2)0002025-11-23
04262429650099Explorer Twin Module STD with spacer0105(1/2)xxx2025-11-23
04262429650105Explorer Twin Module LRG without spacer0105(3/4)0002025-11-23
04262429650112Explorer Twin Module LRG with spacer0105(3/4)xxx2025-11-23
04262429650136Explorer Ring STD0107(1/2)0002025-11-23
04262429650143Explorer Pinch Module STD without spacer0108(1/2)0002025-11-23
04262429650150Explorer Pinch Module spacer0108(1/2)xxx2025-11-23
04262429650204Lynk Hook Module standard020410002025-11-23
04262429650211Lynk Push Module standard020510002025-11-23
04262429650228Lynk Hold STD Module020610002025-11-23
04262429650235Lynk Clic Module020710002025-11-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429650563Lumo Spacer, STD-Amacu4 GmbHISS2025-11-23
04262429650648Lumo Module Connectormacu4 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
00713980038030ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038047ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038054ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038061ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038078ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038085ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038092ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038108ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038115ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038122ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038139ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038146ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038153ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038160ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038177ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038184ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038191ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038207ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038214ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038221ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038238ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038245ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038252ULTRA SEAL LINERAlps South, LLCISS2025-07-03
00713980038269ULTRA SEAL LINERAlps South, LLCISS2025-07-03