FDA.reportPublic FDA data

EZ Mold 8oz Tub Set Pink

Primary DI
00850047788337
Brand
EZ Mold 8oz Tub Set Pink
Company
Westone Laboratories, Inc.
Model
NA
Catalog number
10382
Device description
EZ Mold 8oz Tub Set Pink
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
00850047788337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047788337008500477883378500477883370850047788337

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
Kit
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
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
00850047788092SiliClone FIRM 8pk - no tipsNA101832022-11-29

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