DEVICE: OTSC System Set (04260206310013)
Device Identifier (DI) Information
OTSC System Set
11/3 a
In Commercial Distribution
100.03
Ovesco Endoscopy AG
11/3 a
In Commercial Distribution
100.03
Ovesco Endoscopy AG
The OTSC System Set consists of a clip preloaded onto an application cap • a handwheel and a thread retriever • it can be used in flexible endoscopy for acute bleedings, full thickness wall closure, compression as well as approximation of tissue and management of complications after endoscopic or surgical interventions • the clip closes itself and firmly anchors the tissue • constant force at the implantation site securing the therapeutic effect • made of a biocompatible material (Nitinol), can remain in the body as an implant
Device Characteristics
MR Conditional | |
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? |
---|---|---|---|---|
61208 | Gastrointestinal endoscopic clip, long-term, non-bioabsorbable |
A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PKL | Hemostatic Metal Clip For The Gi Tract |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K101428 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: clip type "a" has blunt teeth |
Device Size Text, specify: thread length 165 cm |
Device Size Text, specify: depth of cap 3 mm |
Device Size Text, specify: endoscope diameter 8.5 - 11 mm |
Device Record Status
a8dbea2f-2f51-402e-884e-48a8f4c8711e
April 07, 2021
6
September 18, 2015
April 07, 2021
6
September 18, 2015
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