Duns Number:007198742
Device Description: "191-NRS Elite Ellik Evac ADAPT NONLOCK"
Catalog Number
-
Brand Name
USA Elite System™ and USA Series™ Ellik Evacuator Adapter, Non-Lockin
Version/Model Number
191-NRS
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
-
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
KQT
Product Code Name
EVACUATOR, GASTRO-UROLOGY
Public Device Record Key
5c708820-88e9-4e65-a5c9-14c8ea0b23d2
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 11, 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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |