FDA.reportPublic FDA data

Lynk Hook Module standard

Primary DI
04262429650204
Brand
Lynk Hook Module standard
Company
macu4 GmbH
Model
02041000
Published
2025-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILTAdaptor, Recreational

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILTAdaptor, RecreationalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262429650204PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262429650204042624296502044262429650204

GMDN Terms#

Term, Definition table
TermDefinition
Wrist/hand orthosisAn externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.

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
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
04262429650211Lynk Push Module standardmacu4 GmbHILT2025-11-23
04262429650228Lynk Hold STD Modulemacu4 GmbHILT2025-11-23
04262429650235Lynk Clic Modulemacu4 GmbHILT2025-11-23
04262429650242Lynk Clic Head 360°macu4 GmbHILT2025-11-23
04262429650259Lynk Clic Head 70°macu4 GmbHILT2025-11-23
04262429650266Lynk Clic Head 0°macu4 GmbHILT2025-11-23
04262429650273Lynk Clic Adaptermacu4 GmbHILT2025-11-23
04262429650327Lynk Clic Lock Modulemacu4 GmbHILT2025-11-23
04262429650334Lynk Clic Lock Head 360°, STDmacu4 GmbHILT2025-11-23
04262429650341Lynk Clic Lock Head 70°, STDmacu4 GmbHILT2025-11-23
04262429650358Lynk Clic Lock Head 0°, STDmacu4 GmbHILT2025-11-23
04262429650365Lynk Clic Lock Adaptermacu4 GmbHILT2025-11-23
04262429650372Lynk Hold Lock Modulemacu4 GmbHILT2025-11-23
04262429650389Lumo Cuff, STD-SML-Amacu4 GmbHILT2025-11-23
04262429650396Lumo Shovel, STDmacu4 GmbHILT2025-11-23
04262429650402Lumo Hold, Lockmacu4 GmbHILT2025-11-23
04262429650419Lumo Roll, STDmacu4 GmbHILT2025-11-23
04262429650426Lumo Clamp, STDmacu4 GmbHILT2025-11-23
04262429650433Lynk Clic Lock Head 70°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650440Lynk Clic Lock Head 0°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650457Lynk Clic Lock Head 360°, ELLIPSEmacu4 GmbHILT2025-11-23
04262429650464Lynk Clic Lock Head 70°, FLATmacu4 GmbHILT2025-11-23
04262429650471Lynk Clic Lock Head 360°, FLATmacu4 GmbHILT2025-11-23
04262429650488Lynk Clic Lock Head 0°, FLATmacu4 GmbHILT2025-11-23
04262429650495Lumo Cuff, STD-SML-Bmacu4 GmbHILT2025-11-23
04262429650501Lumo Cuff, STD-SML-Cmacu4 GmbHILT2025-11-23
04262429650518Lumo Cuff, STD-SML-Dmacu4 GmbHILT2025-11-23
04262429650525Lumo Cuff, STD-SML-Emacu4 GmbHILT2025-11-23
04262429650570Lumo Cuff, STD-MED-Amacu4 GmbHILT2025-11-23
04262429650587Lumo Cuff, STD-MED-Bmacu4 GmbHILT2025-11-23