AccessGUDID - DEVICE: Coleman Mini Style II Kit, 20g x 3cm with Stylet (00081317020349)

GUDID

Device Identifier (DI) Information

Brand Name: Coleman Mini Style II Kit, 20g x 3cm with Stylet
Version or Model: COL-MINI II-K
Commercial Distribution Status: In Commercial Distribution
Catalog Number: COL-MINI II-K
Company Name: MENTOR TEXAS L.P.

Primary DI Number: 00081317020349
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 167450993 *Terms of Use

Device Description: Coleman Mini Style II Kit, 20g x 3.175cm Cannula with Stylet

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:	Yes
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?
45414	Liposuction system cannula, reusable	A rigid tube that functions as a component of a lipectomy suction system and designed specifically for percutaneous insertion into body fat deposits for the aspiration of 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. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
MUU	System, suction, lipoplasty

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 410c5880-0f01-492d-837f-5f3bd8e94c32
Public Version Date: February 21, 2019
Public Version Number: 4
DI Record Publish Date: September 23, 2016