Catalog Number

9012P1322

Brand Name

ManoScan

Version/Model Number

9012P1322

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2017

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

-

Product Code

KLA

Product Code Name

MONITOR, ESOPHAGEAL MOTILITY, AND TUBE

Public Device Record Key

63b2371e-57e7-49a2-93ae-2888b66e2bf7

Public Version Date

September 22, 2022

Public Version Number

6

DI Record Publish Date

May 17, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-