DEVICE: OTSC System Set (04260206310327)

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Device Identifier (DI) Information

OTSC System Set
12/6 a - 220
100.30
Ovesco Endoscopy AG
04260206310327
GS1
1
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
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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.
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FDA Product Code

[?]
Product Code Product Code Name
PKL Hemostatic Metal Clip For The Gi Tract
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: clip type "a" has blunt teeth
Device Size Text, specify: thread length 220 cm
Device Size Text, specify: depth of cap 6 mm
Device Size Text, specify: endoscope diameter 10.5 - 12 mm
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Device Status

In Commercial Distribution
September 18, 2015

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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+49707196528160
service@ovesco.com
+19196519449
customerservice@ovesco-usa.com
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