Duns Number:034094134
Device Description: Curved Probe SC6-1 Gen II®
Catalog Number
SSIP92030
Brand Name
SC6-1 Gen II®
Version/Model Number
SSIP92030
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K142100
Product Code
ITX
Product Code Name
Transducer, ultrasonic, diagnostic
Public Device Record Key
307fb36c-946f-411e-9ed7-db8a153d5d9a
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
October 17, 2016
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 30 |