Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

FL3000

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

K092284,K092482,K092284,K092482

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

4b2d2596-e35b-4681-8edc-be6cc3314894

Public Version Date

July 27, 2022

Public Version Number

2

DI Record Publish Date

March 07, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-