Duns Number:657528899
Device Description: The Word/Bartholin Catheter is used for the treatment of abscesses and cysts of the Bartho The Word/Bartholin Catheter is used for the treatment of abscesses and cysts of the Bartholin gland.
Catalog Number
-
Brand Name
NA
Version/Model Number
WC-400MM
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"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K130087,K130087
Product Code
KNA
Product Code Name
Instrument, Manual, Specialized Obstetric-Gynecologic
Public Device Record Key
f5896f4b-2fbf-4b61-84c9-f9011a24276e
Public Version Date
June 25, 2020
Public Version Number
4
DI Record Publish Date
August 15, 2016
Package DI Number
04715309121986
Quantity per Package
1
Contains DI Package
04715309125038
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 676 |
| U | Unclassified | 1 |