Catalog Number

DWFB-18-02

Brand Name

HARPOON

Version/Model Number

20X1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

June 24, 2024

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K160761,K160761

Product Code

NEW

Product Code Name

Suture, Surgical, Absorbable, Polydioxanone

Public Device Record Key

14797326-b400-43c2-bb72-6a4bba38f849

Public Version Date

June 15, 2021

Public Version Number

1

DI Record Publish Date

June 07, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-