Catalog Number

COL-I16BC

Brand Name

Coleman Infiltration-Style I Curved Cannula, Body

Version/Model Number

COL-I16BC

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

c6d8a984-53ee-42da-bc62-44b01b9a384a

Public Version Date

February 21, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-