Duns Number:178180246
Device Description: Includes 5 Medium Resolution Strideway Tiles, 1 pair of End Caps, 1 Rollout Cover, 2 Strid Includes 5 Medium Resolution Strideway Tiles, 1 pair of End Caps, 1 Rollout Cover, 2 Strideway Power Supply, 2 AC Power Cord for North America, 1 Strideway USB Data Cable, Strideway Software, Equilibration Files, 3162 Sensor Map, 2 Strideway Shipping Cases, PDF of the Users Manual, Printed Copy of the Quick Start Note, and 1 Training Session (USA Only)
Catalog Number
MRSW5
Brand Name
Strideway MR Tile
Version/Model Number
5-Tile Medium Resolution Strideway System
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
JFC
Product Code Name
System, Pressure Measurement, Intermittent
Public Device Record Key
3124f35b-7b86-452b-8bd0-6fd2e53a7d6e
Public Version Date
November 19, 2020
Public Version Number
2
DI Record Publish Date
November 03, 2020
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 | 199 |