DEVICE: Traction Polypectomy Snare (04260206310648)

Device Identifier (DI) Information

Traction Polypectomy Snare
220 cm
In Commercial Distribution
200.55.10
Ovesco Endoscopy AG
04260206310648
GS1

1
344007369 *Terms of Use
Ovesco’s Traction Polypectomy Snare is a newly designed, serrated snare • for endoscopic procedures such as polypectomy, endoscopic mucosa resection (EMR) or similar techniques • specific design - attached teeth to the distal part of the loop - reduces slipping of the snare upon closure • excellent maneuverability and repositioning properties • monopolar high-frequency instrument
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Flexible polypectomy snare, single-use A flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current. It typically consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FDI Snare, Flexible
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K140923 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Device Size Text, specify: loop-diameter (fully open) 25 mm
Device Size Text, specify: working channel diameter 2.8 mm
Device Size Text, specify: working length 220 cm
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Device Record Status

fa4e60f5-20b9-46e0-ba17-7abe266c8016
July 06, 2018
3
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
4260206310549 10 04260206310648 In Commercial Distribution Folding box
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Secondary DI

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

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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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