Duns Number:002144145
Device Description: Uterine Balloon Therapy System
Catalog Number
00825
Brand Name
GYNECARE THERMACHOICE
Version/Model Number
00825
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 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
-
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
c100c859-61b4-4037-8003-947423511960
Public Version Date
March 29, 2018
Public Version Number
2
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 |