DEVICE: SPIES (04048551402610)
Device Identifier (DI) Information
SPIES
11292VSUA
In Commercial Distribution
Karl Storz GmbH & Co. KG
11292VSUA
In Commercial Distribution
Karl Storz GmbH & Co. KG
Flexible Video Choledochoscope
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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 |
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Flexible video 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 the procedure called choledochoscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end and the images showing on a monitor. This device is commonly used to examine structures of the CBD and for the removal of stones. This is a reusable device. |
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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K142556 | 000 |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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Hydrogen Peroxide |
Ethylene Oxide |
Peracetic Acid |
Liquid Chemical |
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
ee33da49-2e39-46ec-8aee-c11ba0055a98
July 06, 2018
3
September 23, 2016
July 06, 2018
3
September 23, 2016
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
[?]
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