Catalog Number

-

Brand Name

Blue Sky Bio, LLC.

Version/Model Number

N50P3

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

K080684,K080684,K080684

Product Code

GAR

Product Code Name

Suture, Nonabsorbable, Synthetic, Polyamide

Public Device Record Key

3ab108ac-e7c5-459a-a551-88befb9bd49f

Public Version Date

February 05, 2021

Public Version Number

6

DI Record Publish Date

October 23, 2015

Package DI Number

10815131022251

Quantity per Package

12

Contains DI Package

00815131022254

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton