Home GUDID G5991030 Aqua Plus Kit
Primary DI G5991030
Brand Aqua Plus Kit
Company Jkr Laboratories, Inc.
Model 103
Published 2024-02-12
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name ESD Hearing Aid, Air-Conduction, Prescription EWD Protector, Hearing (Insert)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class ESD Hearing Aid, Air-Conduction, Prescription Ear, Nose, Throat 1 EWD Protector, Hearing (Insert) Unknown U
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status G5991030 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Earmould impression material A rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is a single-use device.
Regulatory Flags# DUNS number 196376339 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published G599103B0 Aqua Plus Bulk Blue 103B 103B 2025-02-07 G599103R0 Aqua Plus Bulk Red 103R 103R 2025-02-07 G599103D0 Aqua Plus Single Red 2x8 g 103D 2024-02-12 G599103E0 Aqua Plus Single Blue 2x8 g 103E 2024-02-12 G599107A1 Blue Ultra Cartridge 8x50 ml 107A 2024-02-12 G599107C1 Pink Ultra II Cartridge 8x50 ml 107C 2024-02-12 G5991080 Gold Velvet II Impression Single 2x8 g 108 2024-02-12 G599970 Gold Velvet II 10 unit 97 2024-02-12 G59997A0 Gold Velvet II 40 unit 97A 2024-02-12 G59997B0 Gold Velvet II 80 unit 97B 2024-02-12 G599980 XL-300 Impression 660 g 98 2024-02-12 G59998A0 XL-300 Accelerator 25 g 98A 2024-02-12
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