Catalog Number

COL-MINI I

Brand Name

Coleman Mini I Infiltration Cannula 19g x 5cm

Version/Model Number

COL-MINI I

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K981172

Product Code

MUU

Product Code Name

System, suction, lipoplasty

Public Device Record Key

38b015e3-ea3b-46ee-b2fd-dfac1bb47675

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

April 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-