FDA.reportPublic FDA data

Oto-Ease Single Dose - 100/pk

Primary DI
00850047788146
Brand
Oto-Ease Single Dose - 100/pk
Company
Westone Laboratories, Inc.
Model
NA
Catalog number
54017
Device description
Earmold Lubricant
Published
2023-03-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
KMJLubricant, Patient

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMJLubricant, PatientGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047788146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047788146008500477881468500477881460850047788146

GMDN Terms#

Term, Definition table
TermDefinition
General-body orifice lubricantA substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

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
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
08887500730017SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
00627987071429NixitMAYER LABORATORIES, INC.KMJ2025-09-16
06936603230992Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
16936603230999Medical LubricantYangzhou Fartley Medical Instrument Technology Co., LtdKMJ2025-06-23
30080196074192MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
40080196074199MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
17290100666156Sion Biotext Medical Ltd.SION BIOTEXT MEDICAL LTDKMJ2025-04-02
00858276007557Sterile Bacteriostatic Lubricating GelMicro-tech UsaKMJ2025-03-05
00850025860482Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
10850025860489Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860062Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860215Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860277Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007434Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007465Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007496Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850025860079Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860222Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860284Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00858276007441Endoscopy Kit - BasicMicro-tech UsaKMJ2025-03-03
00858276007472Endoscopy Kit - UpperMicro-tech UsaKMJ2025-03-03
00858276007502Endoscopy Kit - Set UpMicro-tech UsaKMJ2025-03-03
00850041319001EsoCoolNuvaira, Inc.KMJ2025-01-29
00850041319018EsoCoolNuvaira, Inc.KMJ2025-01-29
00850058254623EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254630EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254647EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254654EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16