Catalog Number

-

Brand Name

Blue Sky Bio, LLC.

Version/Model Number

PGF40FS2

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

K183004,K183004,K183004

Product Code

GAM

Product Code Name

Suture, Absorbable, Synthetic, Polyglycolic Acid

Public Device Record Key

69962a0f-b5d2-49b1-a76d-baea0ab71e8f

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

December 05, 2019

Package DI Number

20815131027581

Quantity per Package

100

Contains DI Package

10815131027584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case