Duns Number:344007369
Device Description: The OTSC Proctolgy Anchor is one of the OTSC application aids and can be used for treating The OTSC Proctolgy Anchor is one of the OTSC application aids and can be used for treating a lesion before release of the OTSC Proctology clip • it can be used with the OTSC Proctology for grasping and manipulation of tissue in the anorectum • using when the application area of the OTSC Proctology clip cannot be reached with sutures • the head of the instrument is made of Nitinol
Catalog Number
200.61
Brand Name
OTSC Proctology Anchor
Version/Model Number
38 cm
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
KOA
Product Code Name
Surgical Instruments, G-U, Manual (And Accessories)
Public Device Record Key
68264501-b69f-4912-8e8e-cc764dc6bbd4
Public Version Date
October 31, 2019
Public Version Number
5
DI Record Publish Date
September 16, 2016
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 61 |