Catalog Number

CSL-MN103-20

Brand Name

CoolSeal™ Mini

Version/Model Number

CSL-MN103-20

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K202114,K202114

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

154f7328-bcc6-4c28-9abc-6128ef497a34

Public Version Date

September 28, 2022

Public Version Number

3

DI Record Publish Date

October 13, 2020

Package DI Number

10850346007082

Quantity per Package

6

Contains DI Package

00850346007085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case