Catalog Number

10318

Brand Name

Sundash HRF / 20W

Version/Model Number

FR18 T8 PH / BiPin

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 11, 2019

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

6737253d-397d-4d9f-9b9e-7595d06195c6

Public Version Date

December 12, 2019

Public Version Number

3

DI Record Publish Date

June 09, 2017

Package DI Number

84014501000195

Quantity per Package

100

Contains DI Package

54014501400192

Package Discontinue Date

December 11, 2019

Package Status

Not in Commercial Distribution

Package Type

Pallet