Catalog Number

-

Brand Name

Pure Graft Fat Lock System

Version/Model Number

FLS-5US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 06, 2020

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KDQ

Product Code Name

Bottle, Collection, Vacuum

Public Device Record Key

e2b308fe-fe80-4140-ac25-9a49bc5b6e5f

Public Version Date

February 19, 2021

Public Version Number

3

DI Record Publish Date

May 06, 2020

Package DI Number

03701139700249

Quantity per Package

5

Contains DI Package

03701139700232

Package Discontinue Date

May 06, 2020

Package Status

Not in Commercial Distribution

Package Type

Box