Catalog Number

-

Brand Name

HC Biologics

Version/Model Number

HC-OPM100

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

K151543,K151543,K151543

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

8000d6b8-b8fd-4391-8591-d3a9acb74676

Public Version Date

August 24, 2021

Public Version Number

1

DI Record Publish Date

August 16, 2021

Package DI Number

10815634021317

Quantity per Package

5

Contains DI Package

00815634021310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack