Catalog Number

JR-REL25-2.0

Brand Name

JustRight5mm Reload

Version/Model Number

JR-REL25-2.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

K132472,K132472

Product Code

GAG

Product Code Name

STAPLER, SURGICAL

Public Device Record Key

da5bb40b-e2a5-4464-bd84-8f8e5698812f

Public Version Date

May 07, 2019

Public Version Number

5

DI Record Publish Date

August 10, 2015

Package DI Number

10865163000116

Quantity per Package

12

Contains DI Package

00865163000119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case