Duns Number:187129135
Device Description: Straight Spatula Probe with Pre-attached Tubing
Catalog Number
-
Brand Name
Epix Electrosurgical Probe with Smoke Evacuation - Straight Spatula Tip
Version/Model Number
CW004
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
e28ee34f-5ef8-4efd-962a-8133f1b9f580
Public Version Date
September 05, 2019
Public Version Number
1
DI Record Publish Date
August 28, 2019
Package DI Number
10607915139237
Quantity per Package
1
Contains DI Package
00607915139230
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 |