Duns Number:021717889
Device Description: Procedure Set
Catalog Number
M006580210
Brand Name
Genesys HTA ProCerva
Version/Model Number
M006580210
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 19, 2021
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
Yes
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
-
Product Code
MNB
Product Code Name
DEVICE, THERMAL ABLATION, ENDOMETRIAL
Public Device Record Key
f421e10a-af6d-41cc-b1a0-059b67efd4dd
Public Version Date
May 20, 2021
Public Version Number
4
DI Record Publish Date
September 24, 2014
Package DI Number
08714729809463
Quantity per Package
5
Contains DI Package
08714729809456
Package Discontinue Date
January 19, 2021
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |