Catalog Number

-

Brand Name

Sanibel Supply

Version/Model Number

EARturtle

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

For Single-Use

Yes

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

ETT

Product Code Name

Cushion, Earphone (For Audiometric Testing)

Public Device Record Key

c557d4d2-ef8e-4fa8-87d7-6d7ed92b9259

Public Version Date

October 27, 2021

Public Version Number

1

DI Record Publish Date

October 19, 2021

Package DI Number

05711117222081

Quantity per Package

20

Contains DI Package

05711117221848

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box