Catalog Number

-

Brand Name

Blue Sky Bio, LLC.

Version/Model Number

ATTB50W

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

K060957

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Public Device Record Key

f2058f63-17a6-4ae3-9040-7a6fd951b932

Public Version Date

November 08, 2019

Public Version Number

6

DI Record Publish Date

May 04, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-