Catalog Number

FG-2000-00

Brand Name

Carto ENT

Version/Model Number

1

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K161701

Product Code

PGW

Product Code Name

Ear, Nose, and Throat Stereotaxic Instrument

Public Device Record Key

28bcded0-74ed-415d-b9f0-c120b4970a6e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 26, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-