FDA.reportPublic FDA data

Lynk Hold Lock O-2

Primary DI
04262429651102
Brand
Lynk Hold Lock O-2
Company
macu4 GmbH
Model
v1.0
Catalog number
02092001xx
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
ILTAdaptor, Recreational

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILTAdaptor, RecreationalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262429651102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262429651102042624296511024262429651102

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
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
04262429651034Lumo Socket F-1v1.003171001x2026-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429651096Lumo Hold O-2macu4 GmbHILT2026-07-18
04262429650204Lynk Hook Module standardmacu4 GmbHILT2025-11-23
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