Catalog Number

850/PURE

Brand Name

Puregraft

Version/Model Number

850

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

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

K113255,K113255

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

c458d7d4-848d-400b-824f-5aab56aa767d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

10863445000311

Quantity per Package

5

Contains DI Package

00863445000314

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case