STARKEY - STARKEY LABORATORIES, INC.

Duns Number:055461479

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More Product Details

Catalog Number

65757-1

Brand Name

STARKEY

Version/Model Number

3 Series 110 RIC 312

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

Yes

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

7c0a29c1-f2d7-4c96-b9db-9e7400f317b6

Public Version Date

October 06, 2020

Public Version Number

3

DI Record Publish Date

June 29, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STARKEY LABORATORIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 436
2 A medical device with a moderate to high risk that requires special controls. 3346