Catalog Number

AC1600005

Brand Name

12 Pneumatic Endo probes for Endo PAT 2000

Version/Model Number

12 Pneumatic Endo probes for 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

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

K032519

Product Code

DQK

Product Code Name

Computer, Diagnostic, Programmable

Public Device Record Key

e2630e40-d13d-4c1e-9445-f4a1562a7944

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-