Catalog Number

-

Brand Name

Raycell

Version/Model Number

MK1

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

K181737

Product Code

MOT

Product Code Name

Irradiator, Blood To Prevent Graft Versus Host Disease

Public Device Record Key

8868cdb3-8d33-4cda-affe-d5a63f65526b

Public Version Date

January 20, 2020

Public Version Number

2

DI Record Publish Date

July 16, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-