Catalog Number

-

Brand Name

Famidoc

Version/Model Number

FDCO-V1

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LJL

Product Code Name

Detectors And Removers, Lice, (Including Combs)

Public Device Record Key

0e371732-a5db-4885-9886-7530fb30df3a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 29, 2016

Package DI Number

10854314007005

Quantity per Package

40

Contains DI Package

00854314007008

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-