Duns Number:145581588
Device Description: VARIOS YOKE WITH 700-0329-00 CABLE,PACKED,ROHS
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
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
DSH
Product Code Name
RECORDER, MAGNETIC TAPE, MEDICAL
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |