Duns Number:121170653
Device Description: Rigid cardiac sucker, fluted tip, 1/4" connector, 13" length, non-sterile
Catalog Number
SUC-4300
Brand Name
Surge Cardiovascular
Version/Model Number
SUC-4300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 27, 2018
Issuing Agency
In GS1
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
DWF
Product Code Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Public Device Record Key
c5ecc4c0-0841-4af4-b43e-65f746a08a40
Public Version Date
November 02, 2020
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
10817278011273
Quantity per Package
4
Contains DI Package
00817278011931
Package Discontinue Date
March 27, 2018
Package Status
Not in Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |