Catalog Number

103859

Brand Name

ERGOLINE

Version/Model Number

ULTRA 520W

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

2e7e4cf5-124a-4c26-90de-5f1d6cec4b99

Public Version Date

March 10, 2020

Public Version Number

1

DI Record Publish Date

March 02, 2020

Package DI Number

B5331038591

Quantity per Package

25

Contains DI Package

B5331038590

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box