DEVICE: ENTEROSCOPE (04961333232925)
Device Identifier (DI) Information
ENTEROSCOPE
VSB-3430K
In Commercial Distribution
PENTAX OF AMERICA, INC.
VSB-3430K
In Commercial Distribution
PENTAX OF AMERICA, INC.
SMBOWEL ENTEROSCOPE 3.8C 11.6T 2200L FWJ (REFURBISHED)
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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36299 | Flexible video enteroscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the small intestine (duodenum, jejunum, and ileum). It is inserted into the body through the mouth or the anus during enteroscopy typically to examine strictures, assess Crohn's's disease, or take biopsies. It may be designed to be manually inserted or may be designed with features to assist/power insertion (e.g., push/pull double-balloons, powered spiralling motor). 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 reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FDS | Gastroscope And Accessories, Flexible/Rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K962897 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
72cd9915-995c-468a-97e2-8a3f592d07e6
February 21, 2019
4
April 06, 2017
February 21, 2019
4
April 06, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined