Catalog Number

-

Brand Name

HARVEST®

Version/Model Number

51448

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

K103340,K103340

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

e945344a-a299-41a8-9fe6-2aab9ac5cfd7

Public Version Date

September 02, 2022

Public Version Number

5

DI Record Publish Date

July 15, 2017

Package DI Number

35020583514486

Quantity per Package

3

Contains DI Package

05020583514485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-