Catalog Number

-

Brand Name

N/A

Version/Model Number

URI SUV 800-1000/KT/GYH

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K143043,K143043,K143043

Product Code

LEJ

Product Code Name

Booth, Sun Tan

Public Device Record Key

28079dd1-fd6a-4ac3-b8ad-75d6e40f8d1c

Public Version Date

October 25, 2022

Public Version Number

1

DI Record Publish Date

October 17, 2022

Package DI Number

18809909351201

Quantity per Package

12

Contains DI Package

08809909351204

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-