Duns Number:793169512
Device Description: R40-M-R MANUAL COLLIMATOR FOR DR
Catalog Number
6573786
Brand Name
LINEAR MC 150
Version/Model Number
LINEAR MC 150
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 18, 2016
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K810598
Product Code
IZX
Product Code Name
Collimator, manual, radiographic
Public Device Record Key
4c7c7016-aa4a-4179-92c3-3acbfbcb7927
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 16, 2016
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 | 328 |
2 | A medical device with a moderate to high risk that requires special controls. | 688 |