Catalog Number

Catalog Number: 200-10

Brand Name

Firefly

Version/Model Number

Catalog Number: 200-10

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMK

Product Code Name

Lancet, Blood

Public Device Record Key

78794fac-f47b-4bef-930f-b4485835e275

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 14, 2017

Package DI Number

20867396000311

Quantity per Package

10

Contains DI Package

00867396000317

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-