Duns Number:807876284
Device Description: 7.5 cm Delivery Needle and Reflector, SAVI SCOUT®
Catalog Number
SSR75-01
Brand Name
SAVI SCOUT®
Version/Model Number
SSR75-01
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)
Yes
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
ec1a4ec3-8fa4-4427-a711-4e3ac2b979c1
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
November 22, 2017
Package DI Number
10852205006021
Quantity per Package
5
Contains DI Package
00852205006024
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 9 |