DEVICE: Sonicision (10884521592902)

Device Identifier (DI) Information

Sonicision
SCBIGA
In Commercial Distribution

Covidien LP
10884521592902
GS1

1
058614483 *Terms of Use
Reusable Battery Insertion Guide
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
LFL Instrument, ultrasonic surgical
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K180149 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -22 and 140 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

8395103d-ea97-4d3e-856d-72d68f815886
June 24, 2025
6
August 22, 2018
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(508)261-8000
covidien.udi@covidien.com
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