Catalog Number

N/A

Brand Name

Spacelabs Healthcare

Version/Model Number

25452-519

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 06, 2019

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DSH

Product Code Name

RECORDER, MAGNETIC TAPE, MEDICAL

Public Device Record Key

34423c48-340b-4a74-b306-e57b7ec4ff05

Public Version Date

November 08, 2019

Public Version Number

4

DI Record Publish Date

January 05, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-