DEVICE: n.a. (04048551390146)
Device Identifier (DI) Information
n.a.
27023TD
In Commercial Distribution
Karl Storz GmbH & Co. KG
27023TD
In Commercial Distribution
Karl Storz GmbH & Co. KG
Stone Basket, 2.5 Fr., tip, helical
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
44396 | Biliary stone retrieval basket |
A manual instrument designed to be inserted through the working channel of an endoscope to trap, retrieve, and/or manipulate biliary stones for the treatment of conditions such as cholelithiasis (i.e., presence of calculi in the bile duct or gallbladder). It typically consists of a flexible sheath with a braided self-expanding basket [typically made of nickel-titanium alloy (Nitinol)] at the distal end. A handle located at the proximal end of the instrument is designed to open, close, and rotate the basket. The device is typically used in a procedure such as an endoscopic retrograde cholangiopancreatography (ERCP) or a laparoscopic cholecystectomy. This is a single-use device.
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Obsolete | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FBO | CYSTOURETHROSCOPE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K945185 | 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
b7ee7aee-2e72-4afe-b080-a0f80ca457cc
July 06, 2018
3
December 22, 2016
July 06, 2018
3
December 22, 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