Duns Number:809739386
Device Description: SyvekExcel Vascular Access Hemostasis System consists of a kit of 1 reusable handle, 5 alc SyvekExcel Vascular Access Hemostasis System consists of a kit of 1 reusable handle, 5 alcohol prep pads, 5 caps, 5 tegaderm and 5 Syvek Excel Patches. 4 kits are packaged in one case and sold as a unit.
Catalog Number
400-16-05
Brand Name
SyvekExcel Vascular Access Hemostasis System
Version/Model Number
400-16-05
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 06, 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"
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
K053300,K053300
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
74c3931f-456e-4313-a997-21f1bde11b39
Public Version Date
October 06, 2020
Public Version Number
7
DI Record Publish Date
August 05, 2016
Package DI Number
10389142000053
Quantity per Package
4
Contains DI Package
00389142000056
Package Discontinue Date
November 06, 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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |
| U | Unclassified | 2 |