DEVICE: invendoscope (04260444390013)

Device Identifier (DI) Information

invendoscope
SC200
Not in Commercial Distribution

invendo medical GmbH
04260444390013
GS1
November 30, 2017
1
333191497 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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 video colonoscope, single-use An endoscope with a flexible inserted portion intended for the visual examination and treatment of the entire colon [lower gastrointestinal (GI) tract]. It is inserted through the anus during colonoscopy typically to examine the colon (e.g., diseases on the colon) or colon contents (e.g., blood in stools). It may be designed to be manually inserted or designed with features to assist/power insertion (e.g., push/pull double-balloons, powered propelling mechanism). Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FDF Colonoscope And Accessories, Flexible/Rigid
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No 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
No Device Sizes
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Device Record Status

964e5311-4f05-47af-8712-b1bdb7dbb590
February 21, 2019
4
September 22, 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
04260444390020 5 04260444390013 2017-11-30 Not in Commercial Distribution
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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

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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