Duns Number:097462979
Device Description: Myocardial temperature probe, 15mm needle
Catalog Number
215-015
Brand Name
Surge Cardiovascular
Version/Model Number
215-015
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
KRI
Product Code Name
Accessory Equipment, Cardiopulmonary Bypass
Public Device Record Key
0fb7f00b-21dd-4a19-af38-1d5a282cd607
Public Version Date
September 21, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
10817278010153
Quantity per Package
25
Contains DI Package
00817278010156
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 25 |
2 | A medical device with a moderate to high risk that requires special controls. | 91 |