Catalog Number

H704001

Brand Name

EnSite Precision™

Version/Model Number

H704001

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

K201148

Product Code

DQK

Product Code Name

Computer, diagnostic, programmable

Public Device Record Key

ba6244f0-3436-47da-a67a-25d85d0f2395

Public Version Date

June 13, 2022

Public Version Number

1

DI Record Publish Date

June 03, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-