Duns Number:801895244
Device Description: Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient®
Catalog Number
-
Brand Name
Advincula Delineator™ Uterine Manipulator with 3.5 cm Ultem® Koh-Efficient®
Version/Model Number
AD750-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
-
Product Code
HEW
Product Code Name
Culdoscope (And Accessories)
Public Device Record Key
863c1018-b2dd-45c7-a610-b5cf13402110
Public Version Date
February 15, 2021
Public Version Number
5
DI Record Publish Date
September 20, 2016
Package DI Number
20888937012754
Quantity per Package
3
Contains DI Package
00888937012750
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 |