Catalog Number

926295040

Brand Name

CLEO SWIFT

Version/Model Number

FR71T12 CLEO ADVANTAGE XPT 160W-R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 03, 2018

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

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

e15aaea8-2973-44dd-bd56-c85afb7c1bc4

Public Version Date

July 05, 2018

Public Version Number

2

DI Record Publish Date

May 16, 2018

Package DI Number

84014501004001

Quantity per Package

20

Contains DI Package

54014501404008

Package Discontinue Date

July 03, 2018

Package Status

Not in Commercial Distribution

Package Type

Pallet