FDA.reportPublic FDA data

Lucid®

Primary DI
00810068831597
Brand
Lucid®
Company
HEARING LAB TECHNOLOGY, LLC
Model
Custom RIC Sleeve
Catalog number
HLT-CUSTSLEEVE
Device description
Custom Silicone RIC Sleeve
Published
2023-06-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDGKit, earmold, impression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDGKit, Earmold, ImpressionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810068831597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810068831597008100688315978100688315970810068831597

GMDN Terms#

Term, Definition table
TermDefinition
Earmould, custom-madeA custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)785-6052support@lucidhearing.com

Regulatory Flags#

DUNS number
827693503
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810068833119Lucid Hearing®756*LH-Lucid One2026-02-13
00810068833126Lucid Hearing®746*LH-Lucid One-A2026-02-13
00810068833133Lucid Hearing®316*LH-Lucid II2026-02-13
00810068833140Lucid Hearing®306*LH-Lucid II-A2026-02-13
00810068833157Lucid Hearing®616*0LH-Lucid III2026-02-13
00810068833164Lucid Hearing®606*0LH-Lucid III-A2026-02-13
00810068833171Lucid Hearing®306*LH-A64BT-BG-PKG2026-02-13
00810068833188Lucid Hearing®316*LH-U64BT-BG-PKG2026-02-13
00810068833195Lucid Hearing®146*HLT-A32WL-BG-PKG2026-02-13
00810068833201Lucid Hearing®156*HLT-U32WL-BG-PKG2026-02-13
00810068833218Lucid Hearing®906*HLT-SIE16-BG2PK-PKG2026-02-13
00810068832136Lucid Hearing®106*LH-A32BT-BG2025-09-26
00810068832143Lucid Hearing®116*LH-U32BT-BG2025-09-26
00810068832150Lucid Hearing®106*LH-A32BT-GR2025-09-26
00810068832167Lucid Hearing®116*LH-U32BT-GR2025-09-26
00810068832174Lucid Hearing®106*LH-A32BT-BK2025-09-26
00810068832181Lucid Hearing®116*LH-U32BT-BK2025-09-26
00810068832198Lucid Hearing®106*LH-A32BT-BR2025-09-26
00810068832204Lucid Hearing®116*LH-U32BT-BR2025-09-26
00810068832211Lucid Hearing®506*LH-A128BT-PSL2025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00365044000080ComforTen® 60-hole covered trayJubilant Hollisterstier LLCLDG2026-03-02
D239206411egger A/ITE varioInnovation MediTech GmbHLDG2025-08-29
E2392064111egger A/ITE varioInnovation MediTech GmbHLDG2025-08-29
E2392936M1Otoform® A flexDreve Otoplastik GmbHLDG2025-01-20
E2392956M1Otoform® A softXDreve Otoplastik GmbHLDG2025-01-20
E2393206M1Otoform® A softDreve Otoplastik GmbHLDG2025-01-20
E2395041Otoform® KcDreve Otoplastik GmbHLDG2025-01-13
E2398802AU1Otoform® A softX Dreve Otoplastik GmbHLDG2024-03-13
E2398802ST1Otoform® A softX Dreve Otoplastik GmbHLDG2024-03-13
E2398802M1Otoform® A softXDreve Otoplastik GmbHLDG2023-12-18
E23988021Otoform® A softX Dreve Otoplastik GmbHLDG2023-10-31
EPRCA0010200otosil IS-2pro3dure medical GmbHLDG2023-10-18
EPRCA0011000otosil PS-1pro3dure medical GmbHLDG2023-10-18
00850047788153Silicone SINGLES 24 PackWestone Laboratories, Inc.LDG2023-08-25
00850047788160Silicone SINGLES 100 PackWestone Laboratories, Inc.LDG2023-08-25
00850047788177Pink Silicast Westone Laboratories, Inc.LDG2023-08-25
00850047788184Pink SilicastWestone Laboratories, Inc.LDG2023-08-25
00850047788191EZ Mold Singles 24 Pk BlackWestone Laboratories, Inc.LDG2023-08-25
00850047788207EZ Mold Singles 24 Pk BeigeWestone Laboratories, Inc.LDG2023-08-25
00850047788214EZ Mold Singles 24 Pk PinkWestone Laboratories, Inc.LDG2023-08-25
00850047788221EZ Mold Singles 24 Pk PurpleWestone Laboratories, Inc.LDG2023-08-25
00850047788238EZ Mold Singles 24 Pk OrangeWestone Laboratories, Inc.LDG2023-08-25
00850047788245EZ Mold Singles 24 Pk YellowWestone Laboratories, Inc.LDG2023-08-25
00850047788252EZ Mold Singles 24 Pk GreenWestone Laboratories, Inc.LDG2023-08-25
00850047788269EZ Mold Singles 24 Pk BlueWestone Laboratories, Inc.LDG2023-08-25
00850047788276EZ Mold Singles 24 Pk BrownWestone Laboratories, Inc.LDG2023-08-25
00850047788283EZ Mold Singles 24 Pk RedWestone Laboratories, Inc.LDG2023-08-25
00850047788290EZ Mold Singles 24 Pk Forest Green Westone Laboratories, Inc.LDG2023-08-25
00850047788306EZ Mold Singles 22 Pk AssortedWestone Laboratories, Inc.LDG2023-08-25
00850047788313EZ Mold 8oz Tub Set BlackWestone Laboratories, Inc.LDG2023-08-25