Duns Number:713565195
Device Description: Optional parts to protect the FDR MS-3500 from vibration and shock when it is mounted on a Optional parts to protect the FDR MS-3500 from vibration and shock when it is mounted on a vehicle.
Catalog Number
-
Brand Name
Vehicle-monted option
Version/Model Number
DR 3500 MBL KIT HA USA E
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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For Single-Use
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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
MUE
Product Code Name
Full field digital,system,x-ray,mammographic
Public Device Record Key
f5125604-b2b6-4217-aaea-627ab2b7f440
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
April 03, 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 | 43 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 324 |
| 3 | A medical device with high risk that requires premarket approval | 1 |