Catalog Number

045.33C

Brand Name

Crocodile grasp.fcps.insert,d/a,5/330mm C-System

Version/Model Number

045.33C

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

Yes

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

78f9d38e-8300-4d7b-9568-f2dbe8957acd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 03, 2016

Package DI Number

EMAH04533C1

Quantity per Package

1

Contains DI Package

EMAH04533C0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-