Catalog Number

JLL-IN 14 05-N

Brand Name

JULIET ® INSTRUMENTATION

Version/Model Number

JLL-IN 14 05-N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 15, 2019

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

-

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

HTX

Product Code Name

Rongeur

Public Device Record Key

a4a4a4a1-1f6c-48f9-a250-7480916abca4

Public Version Date

July 12, 2019

Public Version Number

2

DI Record Publish Date

January 15, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-