ENDOPRO REVIEW WORKSTATION - ENDOPRO REVIEW WORKSTATION - PENTAX OF AMERICA, INC.

Duns Number:083211284

Device Description: ENDOPRO REVIEW WORKSTATION

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More Product Details

Catalog Number

NA

Brand Name

ENDOPRO REVIEW WORKSTATION

Version/Model Number

KBM68344

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OUG

Product Code Name

Medical Device Data System

Device Record Status

Public Device Record Key

ee899b81-ed52-43e3-80ab-787c28aa808f

Public Version Date

April 03, 2020

Public Version Number

1

DI Record Publish Date

March 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PENTAX OF AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 247
2 A medical device with a moderate to high risk that requires special controls. 425