DEVICE: remOVE DC Cutter Set (04260206310938)
Device Identifier (DI) Information
remOVE DC Cutter Set
12
In Commercial Distribution
400.02.01s
Ovesco Endoscopy AG
12
In Commercial Distribution
400.02.01s
Ovesco Endoscopy AG
The remOVE DC Cutter Set 12 consists of the following products: remOVE DC Cutter is a bipolar endoscopic direct current (DC) instrument for fragmentation of OTSC and FTRD clips in the digestive tract • consists of an insulated conducting wire with an exposed tip • intended to conduct the direct current (DC) supplied by the remOVE DC Impulse to a previously implanted clip • separation of the clip through resistive heating • remOVE DC Cutter is designed to be used only with the remOVE DC Impulse and flexible endoscopes | remOVE SecureCap 12 is an elastic and transparent retrieval cap for safe extraction of the clip fragments | remOVE Grasper is a grasping forceps for retrieval of clip fragments into the remOVE SecureCap • for removal of these fragments out of the GI tract
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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61183 | Gastrointestinal endoscopic clip cutter |
A sterile device intended to be used in combination with a generator to remove a gastrointestinal endoscopic clip. It consists of an insulated conducting wire with an exposed tip intended to be passed through the working channel of an endoscope. It is intended to conduct the direct current (DC) supplied by the generator, to a previously implanted clip, whereby cleavage of the clip occurs through resistive heating. This is a single-use device.
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Active | false |
58841 | Endoscope tissue removal cap, single-use |
A plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue from the path of the endoscope during endoscopic surgery. It is designed to fit tightly without fixing, having an oblique leading edge that extends beyond the end of the endoscope to provide atraumatic penetration and tissue removal functionality (e.g., scooping, grasping). This is a single-use device.
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Active | false |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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QAG | Endoscopic Electrosurgical Clip Cutting System |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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DEN160014 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: for endoscopes diameter 9.5-12 mm |
Device Size Text, specify: working length 220 cm |
Device Size Text, specify: working channel diameter 2.8 mm |
Device Record Status
006a8a4e-85d1-47c0-b0ed-8e2a9c87bd6c
April 07, 2021
7
January 18, 2018
April 07, 2021
7
January 18, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+19196519449
customerservice@ovesco-usa.com +49707196528160
service@ovesco.com
customerservice@ovesco-usa.com +49707196528160
service@ovesco.com