Catalog Number

-

Brand Name

STERiGLIDE TM

Version/Model Number

SGC-050038A

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

Yes

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

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

ba3b9904-d3da-47c7-8f72-6d427ab59072

Public Version Date

April 30, 2020

Public Version Number

1

DI Record Publish Date

April 22, 2020

Package DI Number

14571225317332

Quantity per Package

105

Contains DI Package

04571225317335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-