DEVICE: SONOCA 300 (04250321532667)

Device Identifier (DI) Information

SONOCA 300
15-000B-FL
In Commercial Distribution

Söring GmbH
04250321532667
GS1

1
322238346 *Terms of Use
Ultrasonic generator, 115V
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ultrasonic surgical system generator A mains electricity (AC-powered) component of an ultrasonic surgical system used to generate a high frequency electrical current that is converted, typically within a handpiece, into an ultrasonic oscillation to fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery. The device may also include an integrated suction/aspiration system. This is a reusable device that is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology).
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FDA Product Code

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Product Code Product Code Name
BTA Pump, Portable, Aspiration (Manual Or Powered)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K992026 000
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Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

d58f59a3-56d5-4f98-81f4-4af080c6ec76
July 06, 2018
3
September 17, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
844 476 7464
UDI-inquiry@soering.com
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