Duns Number:204137145
Device Description: Self-sealing sterilization pouches with internal and external multi-variable (parameter) c
Catalog Number
SCI-SCP
Brand Name
Ensure Sterilization Pouch
Version/Model Number
SCI-SCP
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KCT
Product Code Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Public Device Record Key
7ed042d6-6a7b-4593-aa34-625884b0c50f
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
August 30, 2018
Package DI Number
27540196001650
Quantity per Package
20
Contains DI Package
17540196001653
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 114 |