DEVICE: Vitruvian Ultimate Aspirator (B089B890250)

Device Identifier (DI) Information

Vitruvian Ultimate Aspirator
B89025
In Commercial Distribution
B89025
BLACK & BLACK SURGICAL, INC.
B089B890250
HIBCC

1
004382282 *Terms of Use
VITRUVIAN ULTIMATE ASPIRATOR, DUAL MOTOR
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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
Liposuction system An assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers.
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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 [?]
K161722 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

437a921b-6d02-4967-a44e-4b349235be50
August 23, 2018
4
November 23, 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
No
No CLOSE

Customer Contact

[?]
1-877-252-2517
info@blackandblacksurgical.com
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