Duns Number:809524291
Device Description: Sound/Dilator (accessory for ClearView Uterine Manipulator)
Catalog Number
-
Brand Name
ClearView
Version/Model Number
DSD-1000
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
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K940681,K940681
Product Code
LKF
Product Code Name
Cannula, Manipulator/Injector, Uterine
Public Device Record Key
d2a9594f-82ef-4bf8-a01a-c1862c391ca8
Public Version Date
December 07, 2018
Public Version Number
4
DI Record Publish Date
September 01, 2016
Package DI Number
10814247020137
Quantity per Package
50
Contains DI Package
00814247020130
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 12 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 36 |