Duns Number:040729840
Device Description: Mictec High Frequency Cable With Hexagon 4 Millimeter Long Connection: ERBE ACC ICC 5 Mill Mictec High Frequency Cable With Hexagon 4 Millimeter Long Connection: ERBE ACC ICC 5 Millimeter
Catalog Number
-
Brand Name
Mictec High Frequency Cable
Version/Model Number
26944-02
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
-
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
K002877
Product Code
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
4e4f6abf-01c9-4f1e-bf2d-9ac89c31975c
Public Version Date
November 01, 2021
Public Version Number
1
DI Record Publish Date
October 22, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10108 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3414 |