Catalog Number

4475

Brand Name

NA

Version/Model Number

4475

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 17, 2022

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FWF

Product Code Name

CAMERA, TELEVISION, ENDOSCOPIC, WITHOUT AUDIO

Public Device Record Key

51e4fb9b-70da-4be5-bed5-6c61c1d0b55e

Public Version Date

March 18, 2022

Public Version Number

4

DI Record Publish Date

August 23, 2015

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-