DEVICE: HydraSolve Sterile Treatment Ket (00857932006026)

Device Identifier (DI) Information

HydraSolve Sterile Treatment Ket
STK-03
In Commercial Distribution

ANDREW TECHNOLOGIES LLC
00857932006026
GS1

1
831171660 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Liposuction system An assembly of devices used to extract subcutaneous fat from the body during liposuction, a procedure known as a lipectomy, typically performed for body contouring. The system generally consists of an electric-motor suction pump, a cannula, tubing, plastic/glass collection container(s), a vacuum gauge, a vacuum control knob, an overflow trap, and moisture and microbial filters. The pump creates a vacuum in the cannula which is inserted subcutaneously into the fat layer for the removal of adipose tissue (fat) into the collection container. All of the devices in the system that directly contact patient tissue (cannula, tubing, containers, and filters) are single-use.
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FDA Product Code

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Product Code Product Code Name
MUU System, Suction, Lipoplasty
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

Yes
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

7686c9f4-fd89-4d81-82a9-251745cdd15d
March 29, 2018
2
September 22, 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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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