AccessGUDID - DEVICE: PSI-TEC III Aspirator, 110V (00081317023364)

GUDID

Device Identifier (DI) Information

Brand Name: PSI-TEC III Aspirator, 110V
Version or Model: PT-ASP-III-110
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PT-ASP-III-110
Company Name: MENTOR TEXAS L.P.

Primary DI Number: 00081317023364
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 167450993 *Terms of Use

Device Description: PSI-TEC III Aspirator, 110V

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 [?]
K981215	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: b99aa22f-9ff5-45d0-a78a-78cc4169627d
Public Version Date: August 23, 2018
Public Version Number: 4
DI Record Publish Date: September 14, 2016