DEVICE: Gyrus ACMI (00821925040236)
Device Identifier (DI) Information
Gyrus ACMI
E4-9F
Not in Commercial Distribution
Gyrus ACMI, LLC
E4-9F
Not in Commercial Distribution
Gyrus ACMI, LLC
9 French Electrohydraulic Lithotriptor Probe
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
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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? |
---|---|---|---|---|
47098 | Pneumatic lithotripsy system handpiece |
A hand-held component of a pneumatic intracorporeal lithotripsy system designed to hold the system's ballistic probe (i.e., it forms a handle around the probe) and is connected via a dedicated cable to the system's control unit from which energy is transmitted. The handpiece includes connectors and is typically made of metal [e.g., stainless steel, aluminium (Al)] and plastic materials. It may also facilitate suction used for the removal of the fragmented calculi. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FFK | Lithotriptor, electro-hydraulic |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
18a9f0c3-64c2-4f31-8907-347b3937f81f
September 02, 2024
7
October 05, 2016
September 02, 2024
7
October 05, 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 |
---|---|---|---|---|---|
00821925002449 | 3 | 00821925040236 | 2021-06-04 | Not in Commercial Distribution |
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