FDA.reportPublic FDA data

Explorer Swim Module SML without spacer

Primary DI
04262429650075
Brand
Explorer Swim Module SML without spacer
Company
macu4 GmbH
Model
0104(3/4)000
Published
2025-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ISZUnit, Wrist, External Limb Component, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISZUnit, Wrist, External Limb Component, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262429650075PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262429650075042624296500754262429650075

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
true
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
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
04262429650242Lynk Clic Head 360°020720002025-11-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429650884Explorer Hold Lock Modulemacu4 GmbHISZ2026-03-23
04262429650006Explorer Bike Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650013Explorer Bike Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650020Explorer Ball Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650037Explorer Ball Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650044Explorer Ball Module SML without spacermacu4 GmbHISZ2025-11-23
04262429650051Explorer Ball Module SML with spacermacu4 GmbHISZ2025-11-23
04262429650068Explorer Swim Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650082Explorer Twin Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650099Explorer Twin Module STD with spacermacu4 GmbHISZ2025-11-23
04262429650105Explorer Twin Module LRG without spacermacu4 GmbHISZ2025-11-23
04262429650112Explorer Twin Module LRG with spacermacu4 GmbHISZ2025-11-23
04262429650136Explorer Ring STDmacu4 GmbHISZ2025-11-23
04262429650143Explorer Pinch Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650150Explorer Pinch Module spacermacu4 GmbHISZ2025-11-23
04262429650297Explorer Ring EXPmacu4 GmbHISZ2025-11-23
04262429650303Explorer Hold Module STD without spacermacu4 GmbHISZ2025-11-23
04262429650310Explorer Hold Module spacermacu4 GmbHISZ2025-11-23
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