Catalog Number

N/A

Brand Name

Spacelabs Healthcare

Version/Model Number

TAY

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

ccfec247-5a2b-4e1f-8515-641de79f50a4

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

November 24, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-