Catalog Number

SPE-IN 01 94-N

Brand Name

JULIET ® INSTRUMENTATION

Version/Model Number

SPE-IN 01 94-N

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 01, 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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

7fe3880e-13d8-4f07-854c-eeb755b2ee2f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

February 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-