Duns Number:187129135
Device Description: Transanal Access Platform
Catalog Number
-
Brand Name
GelPOINT® Path Transanal Access Platform
Version/Model Number
CNO12
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
FER
Product Code Name
Anoscope And Accessories
Public Device Record Key
2e663b13-6dc1-41c1-97b8-85a630a32237
Public Version Date
October 30, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10607915127647
Quantity per Package
1
Contains DI Package
00607915126742
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 | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |