FDA.reportPublic FDA data

Libby Horn

Primary DI
E239031501
Brand
Libby Horn
Company
Dreve Otoplastik GmbH
Model
03150
Catalog number
03150
Device description
No.
Published
2022-08-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
E239031501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Air-conduction hearing aid acoustic tubeA small tubular detachable device designed to conduct sound waves from an air-conduction hearing aid [e.g., behind-the-ear (BTE)] to an earmould to convey acoustic output to the eardrum. It is made of soft synthetic polymer materials. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
315808340
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E239831001FotoTec® Repair83100831002026-10-14
E239284131Biopor® AB28413284132022-08-18
E23928413M1Biopor® AB28413M28413M2022-08-18
E239284331Biopor® AB28433284332022-08-18
E23928433M1Biopor® AB28433M28433M2022-08-18
E239284431Biopor® AB28443284432022-08-18
E23928443M1Biopor® AB28443M28443M2022-08-18
E23971001FotoTec® SL.A710071002022-08-12
E2397100ST1FotoTec® SL.A7100ST7100ST2022-08-12
E23972001FotoTec® SL.A720072002022-08-12
E239032101Libby Horn03210032102022-08-12
E23903211Libby Horn032103212022-08-12
E23905651Otoferm® Creme056505652024-06-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E239831001FotoTec® RepairDreve Otoplastik GmbHESD2026-10-14
05708296382927BeltoneGn Hearing A/SESD2026-02-10
05708296382934BeltoneGn Hearing A/SESD2026-02-10
05708296382941BeltoneGn Hearing A/SESD2026-02-10
05708296383061BeltoneGn Hearing A/SESD2026-02-10
05708296383078BeltoneGn Hearing A/SESD2026-02-10
05708296383085BeltoneGn Hearing A/SESD2026-02-10
05708296383207BeltoneGn Hearing A/SESD2026-02-10
05708296383214BeltoneGn Hearing A/SESD2026-02-10
05708296383221BeltoneGn Hearing A/SESD2026-02-10
05708296383344BeltoneGn Hearing A/SESD2026-02-10
05708296383351BeltoneGn Hearing A/SESD2026-02-10
05708296383368BeltoneGn Hearing A/SESD2026-02-10
05708296383481GN ReSoundGn Hearing A/SESD2026-02-10
05708296383498GN ReSoundGn Hearing A/SESD2026-02-10
05708296383504GN ReSoundGn Hearing A/SESD2026-02-10
05708296383627GN ReSoundGn Hearing A/SESD2026-02-10
05708296383634GN ReSoundGn Hearing A/SESD2026-02-10
05708296383641GN ReSoundGn Hearing A/SESD2026-02-10
05708296383764GN ReSoundGn Hearing A/SESD2026-02-10
05708296383771GN ReSoundGn Hearing A/SESD2026-02-10
05708296383788GN ReSoundGn Hearing A/SESD2026-02-10
05708296383900GN ReSoundGn Hearing A/SESD2026-02-10
05708296383917GN ReSoundGn Hearing A/SESD2026-02-10
05708296383924GN ReSoundGn Hearing A/SESD2026-02-10
05708296385300GN ReSoundGn Hearing A/SESD2026-02-10
05708296385317GN ReSoundGn Hearing A/SESD2026-02-10
05708296385324GN ReSoundGn Hearing A/SESD2026-02-10
05708296411313BeltoneGn Hearing A/SESD2026-02-10
05708296411320BeltoneGn Hearing A/SESD2026-02-10