Catalog Number

-

Brand Name

Surveyor S4

Version/Model Number

S4-Q-ASX-XXX

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

K141020,K160685

Product Code

DRG

Product Code Name

Transmitters And Receivers, Physiological Signal, Radiofrequency

Public Device Record Key

dcc43dbd-52a6-4c50-8802-378c1afe04f3

Public Version Date

June 29, 2020

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-