Duns Number:809739386
Device Description: Syvek is a 3 cm x 3 cm patch used for vascular hemostasis
Catalog Number
-
Brand Name
Syvek Patch
Version/Model Number
400-02
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
K984177,K984177
Product Code
KMF
Product Code Name
Bandage, Liquid
Public Device Record Key
dfcc62fb-3325-4826-8800-c9ee62f966ac
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
January 20, 2020
Package DI Number
10389142000084
Quantity per Package
6
Contains DI Package
00389142000087
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 |