DEVICE: Sonopet iQ (07613327298642)

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Device Record History
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Device Identifier (DI) Information
Sonopet iQ
5500008300
In Commercial Distribution
5500-008-300
STRYKER CORPORATION
07613327298642
GS1

1
196548481 *Terms of Use
Wireless FP Receiver for 5500008000
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Device Characteristics
MR Unsafe
No
No
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?
36336 Foot-switch, electrical
An electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.
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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 10 and 27 Degrees Celsius
Storage Environment Temperature: between -20 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 85 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
97d3f0c1-e12c-4be2-a7b3-8c42e88df827
May 28, 2020
2
May 03, 2019
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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
No Package DIs found
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Secondary DI

[?]
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

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+0018002533210
Inst.Stryker.cs@Stryker.com
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