Duns Number:435331459
Catalog Number
2506017A
Brand Name
VESALIUS STERILE single-use 2pin american bipolar connector
Version/Model Number
STERILE, L=3m for ESSENTIAL
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
-
Product Code
GEI
Product Code Name
Electrosurgical, Cutting & Coagulation & Accessories
Public Device Record Key
aba92f4a-2b39-4343-8efb-c71bd071b05a
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 28, 2016
Package DI Number
8034055297780
Quantity per Package
5
Contains DI Package
08034055297049
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
double envelope
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 244 |