Duns Number:313217003
Device Description: "syngo.MMWP VE61B Product label - about box"
Catalog Number
-
Brand Name
syngo MultiModality Workplace
Version/Model Number
10409725
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 30, 2016
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
LLZ
Product Code Name
System, image processing, radiological
Public Device Record Key
2a30dd88-9cdc-46f9-afee-a856bbab0d5c
Public Version Date
January 17, 2022
Public Version Number
6
DI Record Publish Date
September 24, 2016
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 478 |
| 3 | A medical device with high risk that requires premarket approval | 1 |