Duns Number:793169512
Device Description: R40-CS-P LIN IV COLLIMATOR W/65 FT CABLE
Catalog Number
6573778
Brand Name
LINEAR IV
Version/Model Number
LINEAR IV
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"
-
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
IZW
Product Code Name
Collimator, automatic, radiographic
Public Device Record Key
3472d461-96f4-48ce-9f9f-9fce0cba8ed7
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 21, 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 |