DEVICE: OTSC System Set (04260206310037)
Device Identifier (DI) Information
OTSC System Set
12/3 a
In Commercial Distribution
100.05
Ovesco Endoscopy AG
12/3 a
In Commercial Distribution
100.05
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Gastrointestinal endoscopic clip, long-term | A sterile 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, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. |
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: thread length 165 cm |
Device Size Text, specify: depth of cap 3 mm |
Device Size Text, specify: endoscope diameter 10.5 - 12 mm |
Device Size Text, specify: clip type "a" has blunt teeth |
Device Record Status
2c69f47f-be44-4afe-94a0-6a8e04d56829
July 06, 2018
3
September 18, 2015
July 06, 2018
3
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