Catalog Number

-

Brand Name

STERiGLIDE TM

Version/Model Number

SGA-040038A

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

a38cbb96-39a9-4dbf-863f-286d3a43d8cb

Public Version Date

April 29, 2021

Public Version Number

1

DI Record Publish Date

April 21, 2021

Package DI Number

14571225317950

Quantity per Package

192

Contains DI Package

04571225317953

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-