Catalog Number
-
Brand Name
STERiGLIDE TM
Version/Model Number
SGC-25050
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
46b73483-5b56-41aa-a66b-249024b36572
Public Version Date
July 28, 2022
Public Version Number
2
DI Record Publish Date
April 07, 2022
Package DI Number
14580708061747
Quantity per Package
2
Contains DI Package
04580708061740
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |