Duns Number:109903521
Device Description: VACUUM PUMP TRUCLEAR OFFICE EU
Catalog Number
72203304
Brand Name
Vario 18 AC 50HZ EU
Version/Model Number
72203304
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 20, 2020
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
NBH
Product Code Name
ACCESSORIES,ARTHROSCOPIC
Public Device Record Key
042122dc-9dfe-4e4b-b335-cb96db48c7e5
Public Version Date
August 21, 2020
Public Version Number
5
DI Record Publish Date
September 28, 2015
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 | 10651 |
2 | A medical device with a moderate to high risk that requires special controls. | 35590 |
3 | A medical device with high risk that requires premarket approval | 351 |