Catalog Number

-

Brand Name

Stradis Medical, LLC.

Version/Model Number

ACC-2550-NG

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

OWL

Product Code Name

Peripheral Catheter Insertion Kit

Public Device Record Key

b05efac3-0afe-4243-b9b2-c7952f921f8e

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

March 19, 2020

Package DI Number

M752ACC2550NG5

Quantity per Package

10

Contains DI Package

M752ACC2550NG0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Box