Duns Number:622766397
Device Description: tube mount, x-ray, diagnostic HQNR
Catalog Number
02000
Brand Name
halo
Version/Model Number
02000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
October 04, 2099
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
IYB
Product Code Name
Tube Mount, X-Ray, Diagnostic
Public Device Record Key
b88bc89e-c5af-4eb6-b284-17e20f10f56f
Public Version Date
August 09, 2021
Public Version Number
4
DI Record Publish Date
November 17, 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 | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |