Duns Number:809739386
Device Description: Syvek Radial Band is a vascular clamp used for radial procedures
Catalog Number
420-02
Brand Name
Syvek Radial Band
Version/Model Number
420-02
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"
Yes
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
K132293,K132293
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
2e5f948b-114e-4533-905b-03804440250e
Public Version Date
September 26, 2018
Public Version Number
4
DI Record Publish Date
August 05, 2016
Package DI Number
20389142000005
Quantity per Package
20
Contains DI Package
00389142000001
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| U | Unclassified | 2 |