Catalog Number

31002

Brand Name

CLEO SWIFT

Version/Model Number

FR71T12 CLEO SWIFT XPT-R 160W

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

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

5330ed14-0ef7-44cb-b9b7-15071316c26f

Public Version Date

December 12, 2019

Public Version Number

2

DI Record Publish Date

May 14, 2018

Package DI Number

84014501003998

Quantity per Package

20

Contains DI Package

54014501403995

Package Discontinue Date

December 10, 2019

Package Status

Not in Commercial Distribution

Package Type

Pallet