Duns Number:744346235
Device Description: 35mm Diameter Trans-Vaginal Tube, 3 Way Valve and Silicone Tie
Catalog Number
C35-TV
Brand Name
ColpotomizOR Tube
Version/Model Number
35mm
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
-
Product Code
HEW
Product Code Name
Culdoscope (And Accessories)
Public Device Record Key
614c3dd8-36f5-4d5a-b5e6-2fb919a92817
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 16, 2017
Package DI Number
09349967001448
Quantity per Package
3
Contains DI Package
09349967001431
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 25 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |