Catalog Number

-

Brand Name

FIBRIJET

Version/Model Number

SA-3662

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

K042834,K042834,K042834

Product Code

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Public Device Record Key

8a206a43-1d6a-4894-ad23-d77b3a7120d2

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 25, 2016

Package DI Number

20815634020065

Quantity per Package

1

Contains DI Package

10815634020068

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

SHIP BOX