DEVICE: OTSC Anchor (04260206310143)

Device Identifier (DI) Information

OTSC Anchor
165 cm
In Commercial Distribution
200.10
Ovesco Endoscopy AG
04260206310143
GS1

1
344007369 *Terms of Use
The OTSC Anchor is one of the OTSC application aids • can be used for treating a lesion before release of the OTSC clip • can be used for better approximation of tissue especially when indurated (e.g. fistulae, chronic ulcer) • facilitates targeting lesions, e.g. in the treatment of hemorrhage • allows precise alignment between the target tissue and the application cap • the head of the instrument is made of Nitinol • a 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

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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 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

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: needle width 12 mm / stich depth 4 mm
Device Size Text, specify: working channel diameter 3.2 mm
Device Size Text, specify: working length 165 cm
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Device Record Status

23cc0847-bd15-474b-825f-7d4da538ef11
March 29, 2018
2
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)

[?]
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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