Duns Number:065963449
Device Description: neXus SonaStar® 1.1 mm Precision Long Curved Tip & Tubeset
Catalog Number
-
Brand Name
neXus
Version/Model Number
130-33-2411
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"
Yes
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
K190160,K190160
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
7a3f0b56-e810-41d6-a7fa-3da03e12db41
Public Version Date
March 03, 2020
Public Version Number
1
DI Record Publish Date
February 24, 2020
Package DI Number
00841626103436
Quantity per Package
5
Contains DI Package
00841626103139
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 91 |
U | Unclassified | 49 |