Catalog Number

115504

Brand Name

CLEO

Version/Model Number

HPA 620FX

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 14, 2021

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

13f2f255-1213-4104-87c5-94ae6d9bc94c

Public Version Date

July 22, 2021

Public Version Number

1

DI Record Publish Date

July 14, 2021

Package DI Number

B5331155041

Quantity per Package

25

Contains DI Package

B5331155040

Package Discontinue Date

July 14, 2021

Package Status

Not in Commercial Distribution

Package Type

carton box