Duns Number:828690904
Device Description: 3 1/2" x 5 1/4" Sterilization Pouches, Built-in color-changing internal and external proce 3 1/2" x 5 1/4" Sterilization Pouches, Built-in color-changing internal and external process indicators, Thumb notch for easy opening, Printed with environmentally-friendly lead-free ink
Catalog Number
1190103
Brand Name
PureLife Dental
Version/Model Number
1190103
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
c7ba474c-a630-4935-89a3-3a4f304bae35
Public Version Date
April 24, 2020
Public Version Number
4
DI Record Publish Date
March 17, 2017
Package DI Number
D79011901033
Quantity per Package
1000
Contains DI Package
D79011901031
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |