Duns Number:344007369
Device Description: The OTSC Twin Grasper is one of the OTSC application aids • facilitates the approximatio The OTSC Twin Grasper is one of the OTSC application aids • facilitates the approximation of gaping edges of a lesion before release of the OTSC clip • two jaws which can be opened separately (two grasping forceps in one device) • working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System
Catalog Number
200.44
Brand Name
OTSC Twin Grasper
Version/Model Number
165 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
5b22f4de-cb6c-4113-96a0-4a5c6e174919
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 |