Duns Number:027680821
Device Description: Provides a method of removing eschar build-up from the tip of an electrosurgical instrumen Provides a method of removing eschar build-up from the tip of an electrosurgical instrument during a procedure.
Catalog Number
-
Brand Name
Sterion® Cautery Tip Cleaner
Version/Model Number
TC-100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 07, 2022
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
Yes
Prescription Use (Rx)
-
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
4f6fecdd-ea0a-425f-b9d8-8ec411d5e85a
Public Version Date
October 14, 2022
Public Version Number
8
DI Record Publish Date
September 17, 2016
Package DI Number
10887761000343
Quantity per Package
100
Contains DI Package
00887761000346
Package Discontinue Date
July 07, 2022
Package Status
Not 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 | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |