Catalog Number

IC12x27

Brand Name

HK Infiltration Microcannula, 11"-12 gauge

Version/Model Number

IC12x27

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

-

Product Code

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Public Device Record Key

6a6825f2-1ad2-4ac9-8e27-e5441ddac5a6

Public Version Date

February 21, 2019

Public Version Number

3

DI Record Publish Date

June 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-