SPACELABS HEALTHCARE - VARIOS YOKE WITH 700-0329-00 CABLE,PACKED,ROHS - SPACELABS HEALTHCARE (WASHINGTON), INC

Duns Number:145581588

Device Description: VARIOS YOKE WITH 700-0329-00 CABLE,PACKED,ROHS

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More Product Details

Catalog Number

700-0327-00

Brand Name

SPACELABS HEALTHCARE

Version/Model Number

LCF; LCF_CABLES; PXCABLES

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2018

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

DSH

Product Code Name

RECORDER, MAGNETIC TAPE, MEDICAL

Device Record Status

Public Device Record Key

5b3e4eff-c0b9-4fc2-9152-6a8c24dbab4b

Public Version Date

November 19, 2018

Public Version Number

3

DI Record Publish Date

August 07, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPACELABS HEALTHCARE (WASHINGTON), INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 732