DEVICE: OTSC Proctology Anchor (04260206310273)
Device Identifier (DI) Information
OTSC Proctology Anchor
38 cm
In Commercial Distribution
200.61
Ovesco Endoscopy AG
38 cm
In Commercial Distribution
200.61
Ovesco Endoscopy AG
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
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33199 | Flexible endoscopic tissue manipulation forceps, single-use |
A flexible, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope to grasp tissue (typically atraumatically), or additionally foreign bodies. It has proximal controls (e.g., scissors-like handles), a flexible long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PTS | Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: needle width 12 mm / stitch depth 4 mm |
Device Size Text, specify: working lenght 38 cm |
Device Record Status
68264501-b69f-4912-8e8e-cc764dc6bbd4
November 03, 2022
6
September 16, 2016
November 03, 2022
6
September 16, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+49707196528160
service@ovesco.com +19196519449
customerservice@ovesco-usa.com
service@ovesco.com +19196519449
customerservice@ovesco-usa.com