Catalog Number

M00552000

Brand Name

NovaGold

Version/Model Number

5200

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OCY

Product Code Name

Endoscopic Guidewire, Gastroenterology-Urology

Public Device Record Key

cf92be03-20e5-44ec-abe6-6a322d191a21

Public Version Date

September 19, 2022

Public Version Number

7

DI Record Publish Date

September 21, 2016

Package DI Number

08714729854418

Quantity per Package

2

Contains DI Package

08714729892038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box