Catalog Number

8926

Brand Name

SharpSafety

Version/Model Number

8926

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2023

Issuing Agency

In GS1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FOX

Product Code Name

STAND, INFUSION

Public Device Record Key

1bae3ab3-2dd5-40c3-8e7f-03babef8036e

Public Version Date

April 29, 2022

Public Version Number

3

DI Record Publish Date

June 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-