Catalog Number

SPE-IN 00 54-N

Brand Name

JULIET INSTRUMENTATION

Version/Model Number

SPE-IN 00 54-N

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

-

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

FZS

Product Code Name

Curette, Surgical, General Use

Public Device Record Key

1669a853-cb1d-4aea-994e-89911ae0a689

Public Version Date

May 07, 2019

Public Version Number

2

DI Record Publish Date

February 11, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-