Catalog Number

-

Brand Name

STERiGLIDE TM

Version/Model Number

SGC-25038

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

345eb9a3-8dbf-494f-b258-334121ed931d

Public Version Date

August 30, 2022

Public Version Number

1

DI Record Publish Date

August 22, 2022

Package DI Number

14580708061556

Quantity per Package

75

Contains DI Package

04580708061559

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-