FotoTec® DLP.B

Primary DI
E239361001
Brand
FotoTec® DLP.B
Company
Dreve Otoplastik GmbH
Model
36100
Catalog number
36100
Device description
No.
Published
2022-09-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ESDHearing aid, air conduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ESDHearing Aid, Air-Conduction, PrescriptionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E239361001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Earmould, custom-madeA custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.

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

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06945936704087NanoXiamen New Sound Technology Co., Ltd.ESD2024-05-21
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06945936703776NewsoundXiamen New Sound Technology Co., Ltd.ESD2024-01-19
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00810126190062AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190079AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
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00810126190093AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190109AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
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00810126190123AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190130AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190147AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
00810126190154AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
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00810126190178AudinaAudina Hearing Instruments, Inc.ESD2023-01-26
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00810126190208AudinaAudina Hearing Instruments, Inc.ESD2023-01-26