FDA.reportPublic FDA data

Blue Silicast Hardener

Primary DI
00850047788436
Brand
Blue Silicast Hardener
Company
Westone Laboratories, Inc.
Model
NA
Catalog number
10402
Device description
Blue Silicast Hardener
Published
2023-08-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
00850047788436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047788436008500477884368500477884360850047788436

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
007087497
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
00850047788160Silicone SINGLES 100 PackNA102052023-08-25
00850047788191EZ Mold Singles 24 Pk BlackNA103302023-08-25
00850047788207EZ Mold Singles 24 Pk BeigeNA103312023-08-25
00850047788238EZ Mold Singles 24 Pk OrangeNA103342023-08-25
00850047788269EZ Mold Singles 24 Pk BlueNA103372023-08-25
00850047788276EZ Mold Singles 24 Pk BrownNA103382023-08-25
00850047788283EZ Mold Singles 24 Pk RedNA103392023-08-25
00850047788306EZ Mold Singles 22 Pk AssortedNA103422023-08-25
00850047788320EZ Mold 8oz Tub Set BeigeNA103812023-08-25
00850047788337EZ Mold 8oz Tub Set PinkNA103822023-08-25
00850047788344EZ Mold 8oz Tub Set PurpleNA103832023-08-25
00850047788368EZ Mold 8oz Tub Set YellowNA103852023-08-25
00850047788405EZ Mold 8oz Tub Set RedNA103892023-08-25
00850047788412EZ Mold 8oz Tub Set Forest GreenNA103912023-08-25
00850047788474Impression Taking Refill KitNA101622023-08-25
00850047788481Impression Taking Starter Kit InternationalNA101632023-08-25
00850047788504Impression Taking Traveler KitNA101662023-08-25
00850047788146Oto-Ease Single Dose - 100/pkNA540172023-03-02
00850047788047SiliClone S-50 - no tipsNA101512022-11-29
00850047788085SiliClone FIRM - 4 tipsNA101822022-11-29

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