AccessGUDID - DEVICE: LIPOSUCTION CANNULA (B0992010080)

GUDID

Device Identifier (DI) Information

Brand Name: LIPOSUCTION CANNULA
Version or Model: 201-008
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B0992010080
Issuing Agency: HIBCC
Commercial Distribution End Date: June 18, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: LIPOSUCTION CANNULA WITH ONE HOLE STRAIGHT

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

GMDN Preferred Term Name	GMDN Definition
Liposuction system cannula, reusable	A rigid tube that is inserted percutaneously to sites of fat deposits, and that functions as part of a lipectomy suction system for the aspiration of the fat during liposuction/lipoplasty. The device may also be used to infiltrate the operative site with a solution during the procedure, which is then aspirated. It is typically made of high-grade stainless steel. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
JOL	Catheter And Tip, Suction

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 180x3mm Tip
Length: 15.75 Inch

Device Record Status

Public Device Record Key: 3188c354-682a-449d-a92a-7d899828e762
Public Version Date: June 18, 2018
Public Version Number: 6
DI Record Publish Date: August 19, 2016