Catalog Number

114073

Brand Name

SUPRA

Version/Model Number

Q-0800SI

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)

-

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

f54b53f9-6fd6-4451-a95a-624892de0e55

Public Version Date

April 21, 2021

Public Version Number

1

DI Record Publish Date

April 13, 2021

Package DI Number

B5331140731

Quantity per Package

25

Contains DI Package

B5331140730

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box