Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

680-089

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MIB

Product Code Name

Elastomer, Silicone Block

Public Device Record Key

f823e61f-1474-4ce8-8e16-fd5e08b80ea1

Public Version Date

June 08, 2022

Public Version Number

1

DI Record Publish Date

May 31, 2022

Package DI Number

M7526800891

Quantity per Package

50

Contains DI Package

M7526800890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case