Catalog Number

-

Brand Name

Blue Sky Bio, LLC

Version/Model Number

SMLJH

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

Yes

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

-

Product Code

EHY

Product Code Name

Tray, Impression, Preformed

Public Device Record Key

e4029c68-3d7e-4e2e-b291-c9d0db6bc0c6

Public Version Date

October 21, 2022

Public Version Number

2

DI Record Publish Date

July 21, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-