AccessGUDID - DEVICE: Vitruvian Infiltration Pump (B089B890550)

GUDID

Device Identifier (DI) Information

Brand Name: Vitruvian Infiltration Pump
Version or Model: B89055
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B89055
Company Name: BLACK & BLACK SURGICAL, INC.

Primary DI Number: B089B890550
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004382282 *Terms of Use

Device Description: VITRUVIAN INFILTRATION PUMP; LED VOLUME DISPLAY - VARIABLE SPEED HIGH FLOW, 100-240VAC

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36894	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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MUU	System, Suction, Lipoplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170629	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0f251c9b-388b-4257-9572-54ef6e45a8cd
Public Version Date: January 23, 2023
Public Version Number: 5
DI Record Publish Date: July 03, 2017