Catalog Number

-

Brand Name

Stradis Medical, LLC

Version/Model Number

HCT6186CP-1

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

FRG

Product Code Name

Wrap, Sterilization

Public Device Record Key

5cc4208d-7f8d-4014-ae4b-077bce21f774

Public Version Date

October 06, 2020

Public Version Number

2

DI Record Publish Date

July 02, 2020

Package DI Number

M752HCT6186CP15

Quantity per Package

30

Contains DI Package

M752HCT6186CP10

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

OUTER BOX