Duns Number:042405446
Device Description: STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating
Catalog Number
SSTD215PRE
Brand Name
Synchro SELECT
Version/Model Number
SSTD215PRE
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
K202522
Product Code
DQX
Product Code Name
Wire, guide, catheter
Public Device Record Key
b92e6a2b-277f-42ea-99e3-5b15bbdd3627
Public Version Date
October 28, 2020
Public Version Number
1
DI Record Publish Date
October 20, 2020
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2688 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5304 |
| 3 | A medical device with high risk that requires premarket approval | 86 |