Duns Number:825284834
Device Description: Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline Mara Water Vapor Probe Kit includes a sterile Mara Water Vapor Probe with attached saline delivery conduit, syringeand saline supply line with spiked end.
Catalog Number
DDK-16-050
Brand Name
Mara Water Vapor Probe Kit
Version/Model Number
DDK-16-050
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
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
P160047
Product Code
MNB
Product Code Name
Device, Thermal Ablation, Endometrial
Public Device Record Key
ce9ab100-8adc-4535-8553-f82edece84c9
Public Version Date
July 30, 2020
Public Version Number
3
DI Record Publish Date
March 16, 2020
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 |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 2 |