Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

HCTBBD-100

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

KYW

Product Code Name

Container, Liquid Medication, Graduated

Public Device Record Key

c98f3241-5e09-4602-8b1e-83bc6e0a24d3

Public Version Date

November 03, 2020

Public Version Number

1

DI Record Publish Date

October 26, 2020

Package DI Number

M752HCTBBD1005

Quantity per Package

20

Contains DI Package

M752HCTBBD1001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

outer box