Catalog Number

35.010.025

Brand Name

Flexible biopsy fcps.,oval cup, 5Fr.,400mm

Version/Model Number

35.010.025

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

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

d5f02a03-f985-4526-9872-1f3160e278bc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 03, 2016

Package DI Number

EMAH350100251

Quantity per Package

1

Contains DI Package

EMAH350100250

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-