Catalog Number

-

Brand Name

FIREFLY®

Version/Model Number

FF-110-04

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

MNI

Product Code Name

Orthosis, Spinal Pedicle Fixation

Public Device Record Key

c3c11195-c824-48e1-9797-f7af2e740db1

Public Version Date

October 19, 2018

Public Version Number

3

DI Record Publish Date

October 25, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-