Duns Number:801895244
Device Description: Advincula Delineator Uterine Manipulator with 3.5cm Soft Koh-Efficient
Catalog Number
-
Brand Name
Advincula Delineator Uterine Manipulator
Version/Model Number
AD750SC-KE35
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
K180429,K180429
Product Code
HEW
Product Code Name
Culdoscope (And Accessories)
Public Device Record Key
d0e9d649-b9c3-4aa4-b8dc-66debce1d29a
Public Version Date
December 07, 2018
Public Version Number
2
DI Record Publish Date
August 13, 2018
Package DI Number
20888937021367
Quantity per Package
3
Contains DI Package
00888937021363
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |