Catalog Number

901935140

Brand Name

Ergoline SR Super Power

Version/Model Number

FR71T12 100W-R

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

6b44077d-c326-4d4a-bd25-22ed80918179

Public Version Date

December 12, 2019

Public Version Number

3

DI Record Publish Date

February 15, 2018

Package DI Number

84014501003899

Quantity per Package

20

Contains DI Package

54014501403896

Package Discontinue Date

December 10, 2019

Package Status

Not in Commercial Distribution

Package Type

Pallet