Catalog Number

081300

Brand Name

JNW URTRAC™

Version/Model Number

081300

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"

-

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

-

Product Code

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

2a2ac0f3-b44d-4ad0-95fd-875e7469e93b

Public Version Date

March 15, 2022

Public Version Number

1

DI Record Publish Date

March 07, 2022

Package DI Number

10850012846229

Quantity per Package

6

Contains DI Package

00850012846222

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case