Duns Number:344007369
Device Description: The OTSG Xcavator is an endoscopic attachment cap for flexible endoscopy that can grasp la The OTSG Xcavator is an endoscopic attachment cap for flexible endoscopy that can grasp large volume of tissue or foreign bodies • for use with standard flexible endoscopes • allows for the use of additional endoscopic instruments or a guide wire through the working channel of the endoscope • flexible shaft • includes an endoscope sleeve and appropriate adhesive tapes
Catalog Number
200.15
Brand Name
OTSG Xcavator
Version/Model Number
Xcavator
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
fa9fe366-4bce-4524-b353-d26198f35e17
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
November 02, 2020
Package DI Number
04260206311300
Quantity per Package
2
Contains DI Package
04260206311317
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Folding box
| 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 |