Catalog Number

-

Brand Name

HARVEST®

Version/Model Number

51449

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"

Yes

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

K043261,K043261

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

101ab122-6106-4418-b80e-23b03b4ef9a7

Public Version Date

September 02, 2022

Public Version Number

5

DI Record Publish Date

September 15, 2016

Package DI Number

35020583514493

Quantity per Package

3

Contains DI Package

05020583514492

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-