Catalog Number

10860-01

Brand Name

SmartGraft™ 200 System

Version/Model Number

10860-01

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2018

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

803cabf7-6850-4d20-8dfd-d300ba6bc8a9

Public Version Date

December 03, 2018

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

-