Duns Number:117056277
Catalog Number
HPSU-01/B
Brand Name
SCOUT®
Version/Model Number
00884450433959
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
Yes
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
NEU
Product Code Name
MARKER, RADIOGRAPHIC, IMPLANTABLE
Public Device Record Key
b96d35f8-0fe1-4a07-b687-e4c04c5b51ba
Public Version Date
March 04, 2022
Public Version Number
1
DI Record Publish Date
February 24, 2022
Package DI Number
10884450433956
Quantity per Package
1
Contains DI Package
00884450433959
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 32 |