Catalog Number

-

Brand Name

STRADIS

Version/Model Number

SS6010B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 02, 2022

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"

-

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

K970814

Product Code

FYC

Product Code Name

Gown, Isolation, Surgical

Public Device Record Key

4a5f9cbc-5ce4-4708-8560-81f7e8ff6575

Public Version Date

March 03, 2022

Public Version Number

4

DI Record Publish Date

May 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-