AccessGUDID - DEVICE: remOVE DC Cutter Set (04260206310921)

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Device Identifier (DI) Information

Brand Name: remOVE DC Cutter Set
Version or Model: 14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 400.02.02s
Company Name: Ovesco Endoscopy AG

Primary DI Number: 04260206310921
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 344007369 *Terms of Use

Device Description: The remOVE DC Cutter Set 14 is part of the remOVE System and 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 14 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

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Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
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.	Active	false
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.	Active	false

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FDA Product Code

Product Code	Product Code Name
QAG	Endoscopic Electrosurgical Clip Cutting System

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FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN160014	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: 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: for endoscopes diameter 12-14 mm
Device Size Text, specify: working length 220 cm
Device Size Text, specify: working channel diameter 2.8 mm

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Device Record Status

Public Device Record Key: 0570ec45-79ec-420d-a36e-149551c18309
Public Version Date: April 07, 2021
Public Version Number: 8
DI Record Publish Date: January 15, 2018

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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)

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
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Production Identifier(s) in UDI

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

Phone: +49707196528160
Email: service@ovesco.com

Phone: +19196519449
Email: customerservice@ovesco-usa.com

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