Fotoplast® S IO - No. - Dreve Otoplastik GmbH

Duns Number:315808340

Device Description: No.

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More Product Details

Catalog Number

4827

Brand Name

Fotoplast® S IO

Version/Model Number

4827

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

e6b99f3f-d16e-43a6-bb7d-e18ed7160c55

Public Version Date

August 22, 2022

Public Version Number

1

DI Record Publish Date

August 12, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DREVE OTOPLASTIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 456