Duns Number:122240021
Device Description: Radiation therapy, machine QA device
Catalog Number
1257000-0MR
Brand Name
MultiMet-WL QA
Version/Model Number
1257000-0MR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IXG
Product Code Name
Phantom, Anthropomorphic, Radiographic
Public Device Record Key
1d67c1f3-3bee-4db1-9827-63c213956dec
Public Version Date
August 22, 2019
Public Version Number
1
DI Record Publish Date
August 14, 2019
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 | 26 |
2 | A medical device with a moderate to high risk that requires special controls. | 112 |