DEVICE: Sonicision (10884521592902)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
60486 | Surgical instrument battery insertion guide |
A non-sterile device intended to protect a sterile, battery-powered surgical instrument during insertion of a non-sterile battery such that the sterility of the surgical instrument is maintained; it may be intended for use preoperatively and/or during surgery. It is typically a shaped template which is designed to fit and cover the profile of the battery insertion port. This is a reusable device intended to be sterilized prior to use.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LFL | Instrument, ultrasonic surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K180149 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between -22 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8395103d-ea97-4d3e-856d-72d68f815886
June 24, 2025
6
August 22, 2018
June 24, 2025
6
August 22, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20884521592909 | 2 | 10884521592902 | In Commercial Distribution | PACK_OR_INNER_PACK | |
30884521592906 | 16 | 20884521592909 | In Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+1(508)261-8000
covidien.udi@covidien.com
covidien.udi@covidien.com