FDA.reportPublic FDA data

Otoferm® Creme

Primary DI
E23905651
Brand
Otoferm® Creme
Company
Dreve Otoplastik GmbH
Model
0565
Catalog number
0565
Device description
No.
Published
2024-06-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
E23905651PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Moisture/lubrication otic solutionAn aqueous solution intended to be applied to the external auditory canal of the ear to provide moisture and/or lubrication typically to facilitate softening and/or removal of ear wax, removal of impurities, barrier to external water, and/or loosening of encrustations; it may in addition have antimicrobial and/or anti-inflammatory actions. It is typically a solution of saline or compounds such as plant extracts, and/or surfactants applied as a spray or as drops. It is normally available [non-prescription] over-the-counter (OTC). After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49230388070otoplastik@dreve.de

Regulatory Flags#

DUNS number
315808340
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
E239032101Libby Horn03210032102022-08-12
E23903211Libby Horn032103212022-08-12
E239031501Libby Horn03150031502022-08-12
E239904001FotoTec® DLP.C90400904002026-01-30
E239905001FotoTec® DLP.C90500905002026-01-30
E239361001FotoTec® DLP.B36100361002022-09-15
E239906001FotoTec® DLP.C90600906002026-01-15
E2390871SK 87 Silicone glue0870872022-08-12
E239903001FotoTec® DLP.C90300903002025-07-09
E239908001FotoTec® DLP.C90800908002025-07-09
E2399095011FotoTec® DLP.C9095019095012025-07-09
E239901001FotoTec® DLP.C90100901002025-04-02
E23942511Biopor® UV-S425142512023-10-11
E2392936M1Otoform® A flex2936M2936M2025-01-20
E2392956M1Otoform® A softX2956M2956M2025-01-20
E2393206M1Otoform® A soft3206M3206M2025-01-20
E23904171101Pre-bent tubing041711004171102025-01-13
E23904171501Pre-bent tubing041715004171502025-01-13
E239042501Pre-bent tubing04250042502025-01-13
E23911311Silicone tubing113111312025-01-13

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