Sonopal® soft Lacquer E - No. - Innovation MediTech GmbH

Duns Number:313785693

Device Description: No.

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More Product Details

Catalog Number

M111507

Brand Name

Sonopal® soft Lacquer E

Version/Model Number

M111507

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

ESD

Product Code Name

Hearing aid, air conduction

Device Record Status

Public Device Record Key

ad269910-7334-41c8-9fc3-bcb3ddfd9e9c

Public Version Date

September 29, 2020

Public Version Number

1

DI Record Publish Date

September 21, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INNOVATION MEDITECH GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7
2 A medical device with a moderate to high risk that requires special controls. 8