Duns Number:841522985
Device Description: 360" Coiled extension set
Catalog Number
SMES360
Brand Name
Summit International
Version/Model Number
SMES360
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
April 30, 2024
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
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
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
0d3b2999-4a86-4915-9ece-2942bef950d4
Public Version Date
May 12, 2021
Public Version Number
1
DI Record Publish Date
May 04, 2021
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. | 14 |