Catalog Number

685ME/C

Brand Name

StayFIX®

Version/Model Number

00884450021026

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

fe967186-5ca9-4ea8-99c9-74a5fdb6495b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 16, 2018

Package DI Number

10884450021023

Quantity per Package

20

Contains DI Package

00884450021026

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-