FDA.reportPublic FDA data

Sonopal® soft Lacquer E

Primary DI
E239M1115071
Brand
Sonopal® soft Lacquer E
Company
Innovation MediTech GmbH
Model
M111507
Catalog number
M111507
Device description
No.
Published
2020-09-21
Public version status
New
Distribution status
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
E239M1115071PrimaryHIBCC0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature18 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
313785693
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
D239206411egger A/ITE vario20641206412025-08-29
E2392064111egger A/ITE vario2064112064112025-08-29
E239M700101VITA ENAMIC GLAZE1M700102016-10-18
E239M700111VITA ENAMIC STAINS LIQUID1M700112016-10-18
E239M7001211VITA ENAMIC STAIN white1M7001212016-10-18
E239M7001221VITA ENAMIC STAIN corn1M7001222016-10-18
E239M7001231VITA ENAMIC STAIN brown1M7001232016-10-18
E239M7001241VITA ENAMIC STAIN blue1M7001242016-10-18
E239M7001251VITA ENAMIC STAIN black1M7001252016-10-18
E239M7001261VITA ENAMIC STAIN khaki1M7001262016-10-18
E239M1113001 Sonopal® hard Lacquer AlM111300M1113002020-09-21
E239M1113031Sonopal® hard Lacquer Al M111303M1113032020-09-21
E239M1113041Sonopal® hard Lacquer AlM111304M1113042020-09-21
E239M1113091Sonopal® hard Lacquer AlM111309M1113092020-09-21
E239M1115041Sonopal® soft Lacquer EM111504M1115042020-09-21
E239M1115051Sonopal® soft Lacquer EM111505M1115052020-09-21

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