Duns Number:694335852
Device Description: 475x475mm, 180cm focus, 1.78mm thick, 70lines per cm Al, CFRP, 13:1
Catalog Number
-
Brand Name
MS X-RAY GRID
Version/Model Number
S2007AC
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
-
Product Code
IXJ
Product Code Name
Grid, Radiographic
Public Device Record Key
3b9f6814-dc83-44ce-af62-fd9e3cacfe0c
Public Version Date
June 01, 2020
Public Version Number
1
DI Record Publish Date
May 22, 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 | 119 |