Catalog Number

JTL-250-01

Brand Name

MiniTC

Version/Model Number

JTL-250-01-US

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K182732,K182732

Product Code

MUU

Product Code Name

System, Suction, Lipoplasty

Public Device Record Key

2ab591d1-adf4-41fc-81cf-f78e15d7a53f

Public Version Date

January 19, 2022

Public Version Number

1

DI Record Publish Date

January 11, 2022

Package DI Number

00860003545232

Quantity per Package

6

Contains DI Package

00860003545218

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PK