Duns Number:603420183
Device Description: 10 cm FS® SOUNDBase Package Type - EachOne (1) non-sterile, reusable 10 cm FS® SOUND for u 10 cm FS® SOUNDBase Package Type - EachOne (1) non-sterile, reusable 10 cm FS® SOUND for use with the McCarus-Volker FORNISEE® System.
Catalog Number
110105
Brand Name
McCarus-Volker FORNISEE® System
Version/Model Number
110105
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
-
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
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
8f3c0804-bda9-4006-91c0-20bc70a56f1f
Public Version Date
July 16, 2020
Public Version Number
4
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 |