Catalog Number

JR-SE20

Brand Name

JustRight Sealer

Version/Model Number

JR-SE20

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

K123662,K123662

Product Code

GEI

Product Code Name

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Public Device Record Key

6d165e78-f06d-4e62-9557-8c8ea9fcde1b

Public Version Date

April 23, 2019

Public Version Number

4

DI Record Publish Date

August 10, 2015

Package DI Number

10865163000123

Quantity per Package

6

Contains DI Package

00865163000126

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case