Duns Number:117056277
Catalog Number
SSR75-01/D
Brand Name
SCOUT®
Version/Model Number
00884450434789
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
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
e006bc84-3967-4ffd-b4d6-7a4ffaa26b55
Public Version Date
October 11, 2021
Public Version Number
2
DI Record Publish Date
January 19, 2021
Package DI Number
20884450434783
Quantity per Package
16
Contains DI Package
10884450434786
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 |