Catalog Number

35.010.017

Brand Name

Flexible foreign body fcps.,alligator, 7Fr.,400mm

Version/Model Number

35.010.017

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

FCL

Product Code Name

FORCEPS, BIOPSY, NON-ELECTRIC

Public Device Record Key

cea4a424-9de6-418b-8a7a-d65938fd83ba

Public Version Date

June 04, 2018

Public Version Number

1

DI Record Publish Date

May 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-