Catalog Number

CSL-TR105-30

Brand Name

CoolSeal™ Trinity

Version/Model Number

CSL-TR105-30

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,K203183,K211579,K202114,K203183,K211579

Product Code

GEI

Product Code Name

Electrosurgical, cutting & coagulation & accessories

Public Device Record Key

43a7857d-c41b-4443-8d93-54475bae9129

Public Version Date

September 28, 2022

Public Version Number

3

DI Record Publish Date

October 13, 2020

Package DI Number

10850346007037

Quantity per Package

6

Contains DI Package

00850346007030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case