Duns Number:007198742
Device Description: "166 KE HF CABLE ERBE ACC/ICC"
Catalog Number
-
Brand Name
HF CABLE ERBE ACC/ICC
Version/Model Number
166 KE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 11, 2017
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
-
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
K971881
Product Code
FJL
Product Code Name
RESECTOSCOPE
Public Device Record Key
9e2a149c-261d-4c95-b94a-d9dd3ff8b36a
Public Version Date
October 06, 2022
Public Version Number
4
DI Record Publish Date
May 10, 2017
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 | 899 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1586 |
| 3 | A medical device with high risk that requires premarket approval | 9 |
| U | Unclassified | 4 |