Catalog Number

FP020

Brand Name

FLEXIPATH

Version/Model Number

FP020

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

-

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Public Device Record Key

488b3c72-8a7b-4389-b3fb-4437888f0daf

Public Version Date

October 16, 2019

Public Version Number

5

DI Record Publish Date

July 15, 2016

Package DI Number

30705036011921

Quantity per Package

36

Contains DI Package

10705036011927

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE