Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

IM2201

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

-

Product Code Name

-

Public Device Record Key

da056445-6082-4df1-b208-5f5459d6c0de

Public Version Date

December 11, 2019

Public Version Number

2

DI Record Publish Date

August 13, 2019

Package DI Number

M752IM22015

Quantity per Package

50

Contains DI Package

M752IM22010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box