DEVICE: FIBER PANCREATOSCOPE (04961333232727)
Device Identifier (DI) Information
FIBER PANCREATOSCOPE
FCP-8P
Not in Commercial Distribution
PENTAX OF AMERICA, INC.
FCP-8P
Not in Commercial Distribution
PENTAX OF AMERICA, INC.
PERORAL CHOLEDOCHO, FIBER SCOPE, TD2.7,C (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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34939 | Flexible fibreoptic choledochoscope |
An endoscope with a flexible inserted portion intended for the visual examination and treatment of the choledoc, better known as the common bile duct (CBD). It is inserted into the body through an artificial orifice created by an incision in the abdomen (laparoscopic technique), or introduced via a flexible duodenoscope during choledochoscopy. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This device is commonly used to examine structures of the CBD and for the removal of stones. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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FBN | Choledochoscope And Accessories, Flexible/Rigid |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K953286 | 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
63c121de-39f2-40e7-9368-01c3c808e3f4
July 06, 2018
3
April 06, 2017
July 06, 2018
3
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
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No Customer Contact currently defined