Duns Number:347449352
Device Description: Transvaginal Cannula with its pointed trocar, devised for introduction in the pouch of Dou Transvaginal Cannula with its pointed trocar, devised for introduction in the pouch of Douglas in order to perform a Transvaginal hydro-pelviscopy
Catalog Number
-
Brand Name
FertiloScope
Version/Model Number
FTO 1.40
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 10, 2021
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
HET
Product Code Name
Laparoscope, Gynecologic (And Accessories)
Public Device Record Key
a0817c5c-2f65-4827-85ab-5fa32831afe5
Public Version Date
February 11, 2021
Public Version Number
4
DI Record Publish Date
October 17, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| U | Unclassified | 6 |