Catalog Number

114062

Brand Name

ERGOLINE

Version/Model Number

JK 60/80 EF

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

6c0c427b-c122-4655-a7f8-a746859d76aa

Public Version Date

December 15, 2020

Public Version Number

1

DI Record Publish Date

December 07, 2020

Package DI Number

B5331140621

Quantity per Package

25

Contains DI Package

B5331140620

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton box