Catalog Number

-

Brand Name

PENTAX

Version/Model Number

OE-A51

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

K130206,K130206

Product Code

ODG

Product Code Name

Endoscopic ultrasound system, gastroenterology-urology

Public Device Record Key

8ca60526-85df-427b-9037-181aad949a13

Public Version Date

March 22, 2022

Public Version Number

5

DI Record Publish Date

April 07, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-