DEVICE: OTSC Twin Grasper (04260206310235)

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Device Identifier (DI) Information

OTSC Twin Grasper
220 cm
200.45
Ovesco Endoscopy AG
04260206310235
GS1
1
The OTSC Twin Grasper is one of the OTSC application aids • facilitates the approximation of gaping edges of a lesion before release of the OTSC clip • two jaws which can be opened separately (two grasping forceps in one device) • working channel diameter of at least 3.2 mm is required when used in combination with the OTSC System
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Device Characteristics

Labeling does not contain MRI Safety Information
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
Flexible endoscopic grasping forceps, single-use A flexible manual device intended to be used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissors-like grasping tongs or claws which are operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KOA Surgical Instruments, G-U, Manual (And Accessories)
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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: working channel diameter 3.2 mm
Device Size Text, specify: working length 220 cm
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Device Status

In Commercial Distribution
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
No Package DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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