Catalog Number

AS1650030

Brand Name

Endo PAT 2000

Version/Model Number

Endo PAT 2000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K032519,K032519

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Public Device Record Key

46711195-8b89-4d62-8c0b-c8f82042e75b

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

December 31, 2017

Package DI Number

07290109225364

Quantity per Package

1

Contains DI Package

07290109225371

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton