Duns Number:277657631
Device Description: Disposable single use tips with sheath for air/water syringe.
Catalog Number
201750
Brand Name
Total protec by RISKONTROL
Version/Model Number
RISKONTROL
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECB
Product Code Name
Unit, Syringe, Air And/Or Water
Public Device Record Key
b798286f-8e3f-400d-816d-7c9e94828f70
Public Version Date
September 28, 2022
Public Version Number
1
DI Record Publish Date
September 20, 2022
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 7 |