Duns Number:071595540
Device Description: RFB, POWERPRO SYSTEM STERILIZATION CASE, SMALL
Catalog Number
PRO5095RFB
Brand Name
POWERPRO
Version/Model Number
PRO5095RFB
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 09, 2022
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K090560,K090560
Product Code
KCT
Product Code Name
Sterilization wrap containers, trays, cassettes & other accessories
Public Device Record Key
d36cac8d-9058-4e8a-afa4-7bebfb2346bb
Public Version Date
September 16, 2022
Public Version Number
10
DI Record Publish Date
October 14, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |