Catalog Number
815000-031
Brand Name
VIASYS QDC CABLE GREEN
Version/Model Number
815000-031
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 07, 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"
Yes
For Single-Use
Yes
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
LXJ
Product Code Name
System, Optical Position/Movement Recording
Public Device Record Key
34d646b2-4f28-4ee5-be4d-07863f870319
Public Version Date
February 07, 2019
Public Version Number
1
DI Record Publish Date
January 07, 2019
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 | 1 |
2 | A medical device with a moderate to high risk that requires special controls. | 309 |