Duns Number:187129135
Device Description: Angled Spatula Probe with Pre-attached Tubing
Catalog Number
-
Brand Name
Epix Electrosurgical Probe with Smoke Evacuation - Angled Spatula Tip
Version/Model Number
CW001
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
4e7200ac-c076-4499-8d82-0b5cc4fe6ff8
Public Version Date
February 21, 2019
Public Version Number
2
DI Record Publish Date
October 05, 2018
Package DI Number
10607915136151
Quantity per Package
1
Contains DI Package
00607915136154
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |