Catalog Number

35.010.025SR

Brand Name

Flexible biopsy fcps.,oval cup, 5Fr.,400mm, semi-rigid

Version/Model Number

35.010.025SR

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

84cf1b28-19ea-4683-92b8-7baece42c76d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 03, 2016

Package DI Number

EMAH35010025SR1

Quantity per Package

1

Contains DI Package

EMAH35010025SR0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-