Catalog Number

101-99

Brand Name

Flow-Nail™

Version/Model Number

101-99

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K140601

Product Code

LRP

Product Code Name

Tray, Surgical

Public Device Record Key

6385c28a-6d97-4d85-bd4a-df1033b16f3b

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

February 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-