FDA.reportPublic FDA data

Gold Velvet II Impression Single 2x8 g

Primary DI
G5991080
Brand
Gold Velvet II Impression Single 2x8 g
Company
Jkr Laboratories, Inc.
Model
108
Device description
ear impression material
Published
2024-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ESDHearing Aid, Air-Conduction, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G5991080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Earmould impression materialA 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.

Sterilization Methods#

Method table
Method

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 DIBrandModelCatalogPublished
G599103B0Aqua Plus Bulk Blue103B103B2025-02-07
G599103R0Aqua Plus Bulk Red103R103R2025-02-07
G5991030Aqua Plus Kit1032024-02-12
G599103D0Aqua Plus Single Red 2x8 g103D2024-02-12
G599103E0Aqua Plus Single Blue 2x8 g103E2024-02-12
G599107A1Blue Ultra Cartridge 8x50 ml107A2024-02-12
G599107C1Pink Ultra II Cartridge 8x50 ml107C2024-02-12
G599970Gold Velvet II 10 unit972024-02-12
G59997A0Gold Velvet II 40 unit97A2024-02-12
G59997B0Gold Velvet II 80 unit 97B2024-02-12
G599980XL-300 Impression 660 g982024-02-12
G59998A0XL-300 Accelerator 25 g98A2024-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613389772838ampli-mini I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772845ampli-mini I 2 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772920MEMINI I 4 5P CIC-10 NWL PHSonova AGESD2024-11-12
07613389772937MEMINI I 3 5P CIC-10 NWL PHSonova AGESD2024-11-12
EDET038421luxaprint 3D shell white 500gDETAX GmbHESD2024-08-28
06945936704070NanoXiamen New Sound Technology Co., Ltd.ESD2024-05-21
06945936704087NanoXiamen New Sound Technology Co., Ltd.ESD2024-05-21
16945936703773NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
06945936703776NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
00810126190000AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190017AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190024AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190031AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190048AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190055AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190062AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190079AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190086AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190093AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190109AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190116AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190123AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190130AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190147AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190154AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190161AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190178AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190185AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190192AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190208AudinaAudina Hearing Instruments, Inc.ESD2023-01-26