Duns Number:603420183
Device Description: FS-30 FORNISEE® DEVICEBase Package Type - EachEach sterile package contains (1) single pat FS-30 FORNISEE® DEVICEBase Package Type - EachEach sterile package contains (1) single patient use disposable FS-30 FORNISEE® Device, uterine manipulator, for use only with the McCarus-Volker FORNISEE® System.30 mm Cervical Cup
Catalog Number
110030
Brand Name
McCarus-Volker FORNISEE® System
Version/Model Number
110030
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)
Yes
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
K111014,K111014
Product Code
HEW
Product Code Name
Culdoscope (And Accessories)
Public Device Record Key
66945945-b817-4c27-a6c9-c71229fc2b51
Public Version Date
July 16, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10850200006213
Quantity per Package
6
Contains DI Package
00850200006216
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 56 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |