Catalog Number

901140

Brand Name

Map-iT

Version/Model Number

901140

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

K160390

Product Code

DRF

Product Code Name

Catheter, Electrode Recording, Or Probe, Electrode Recording

Public Device Record Key

184f0b20-98b5-4d25-ab0f-a7c0a5c8b5ba

Public Version Date

May 19, 2020

Public Version Number

2

DI Record Publish Date

October 18, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-