Catalog Number

-

Brand Name

Blue Sky Bio, LLC

Version/Model Number

ITW5614

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

K051507

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Public Device Record Key

93e6e58a-ec26-45a8-a1d2-87f3393332b0

Public Version Date

October 18, 2019

Public Version Number

4

DI Record Publish Date

October 24, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-