Duns Number:315304071
Device Description: SPRAY ATTACHMENT for CombiDrive EN Motor Control Unit, for Clean Spray for cleaning of th SPRAY ATTACHMENT for CombiDrive EN Motor Control Unit, for Clean Spray for cleaning of the micro motor
Catalog Number
40900.1202
Brand Name
COMBIDRIVE EN
Version/Model Number
409001202
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"
-
For Single-Use
-
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
HET
Product Code Name
LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
Public Device Record Key
0ef6f3ce-db2d-4805-913c-c411158fe865
Public Version Date
December 24, 2018
Public Version Number
4
DI Record Publish Date
July 21, 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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |