Catalog Number

-

Brand Name

Blue Sky Bio, LLC.

Version/Model Number

DRILLN43S

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

-

Product Code

EBL

Product Code Name

Pin, Retentive And Splinting, And Accessory Instruments

Public Device Record Key

6ba1b993-fead-418b-95f6-959e5cf11228

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

August 06, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-