Duns Number:002144145
Device Description: Uterine Balloon Therapy System with Fluid Circulation
Catalog Number
TC013
Brand Name
GYNECARE THERMACHOICE
Version/Model Number
TC013
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 02, 2018
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
7c43cbc5-98e5-4b6d-90cd-fa8fdbba0d3a
Public Version Date
April 20, 2020
Public Version Number
3
DI Record Publish Date
September 20, 2014
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1128 |
| 3 | A medical device with high risk that requires premarket approval | 4 |
| U | Unclassified | 1 |