Catalog Number

-

Brand Name

GeniLook

Version/Model Number

200-015-151

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K982472

Product Code

GEA

Product Code Name

Cannula, Surgical, General & Plastic Surgery

Public Device Record Key

9065dd81-7ae0-4339-957e-f3efe78e2360

Public Version Date

January 09, 2020

Public Version Number

2

DI Record Publish Date

June 06, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-