Catalog Number

JR-125 ECO-10

Brand Name

JustRight 5mm Retrieval bag, 125ml

Version/Model Number

JR-125 ECO-10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 23, 2017

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

K111845,K111845

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

7c2320e9-5cec-4f6e-9492-3d62b09258a9

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 18, 2016

Package DI Number

10850346007013

Quantity per Package

10

Contains DI Package

00850346007016

Package Discontinue Date

February 23, 2017

Package Status

Not in Commercial Distribution

Package Type

Case