FDA.reportPublic FDA data

SiliClone FIRM 8pk - 32 tips

Primary DI
00850047788108
Brand
SiliClone FIRM 8pk - 32 tips
Company
Westone Laboratories, Inc.
Model
NA
Catalog number
10184
Device description
SiliClone FIRM 8pk - 32 tips
Published
2022-11-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047788108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047788108008500477881088500477881080850047788108

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
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