FDA.reportPublic FDA data

Explorer Twin Module LRG with spacer

Primary DI
04262429650112
Brand
Explorer Twin Module LRG with spacer
Company
macu4 GmbH
Model
0105(3/4)xxx
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
04262429650112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262429650112042624296501124262429650112

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
04262429651089Explorer Hold Lock O-2 Modulemacu4 GmbHISZ2026-07-18
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
04262429650075Explorer Swim Module SML 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
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
09421037390383Low Profile Lamination Kit, CX, 50mm TASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390451MC Seal Ring Kit, Medium/Large, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390505TASKA Seal Ring Kit, 50mm, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785425MC Seal Ring Kit, Medium/Large, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785432TASKA Seal Ring Kit, 50mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785944MC Seal Ring Kit, Small, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785951MC Seal Ring Kit, Small, Sand TASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785982TASKA Seal Ring Kit, 45mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421906785999TASKA Seal Ring Kit, 45mm, SandTASKA PROSTHETICS LIMITEDISZ2025-07-29
09421037390390TASKA Lamination Collar Kit (6-band), 50mm, BlackTASKA PROSTHETICS LIMITEDISZ2025-07-28
09421037390406TASKA Lamination Collar Kit (6-band), 50mm, Sand TASKA PROSTHETICS LIMITEDISZ2025-07-28