Duns Number:603420183
Device Description: Combo Box of 6 FS FORNISEE® DEVICESBase Package Type - KitThe combo box contains two (2) e Combo Box of 6 FS FORNISEE® DEVICESBase Package Type - KitThe combo box contains two (2) each of sterile single patient use disposable FS-30, FS-35, and FS-40 FORNISEE® Devices, uterine manipulators, for use only with the McCarus-Volker FORNISEE® System.2 each of 30 mm, 35 mm, and 40 mm Cervical Cups
Catalog Number
110029
Brand Name
McCarus-Volker FORNISEE® System
Version/Model Number
110029
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
K111014
Product Code
HEW
Product Code Name
Culdoscope (And Accessories)
Public Device Record Key
26c073b8-2cf2-4502-9337-25e56d665b1f
Public Version Date
July 16, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2016
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 | 56 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 31 |