Duns Number:238476068
Device Description: Hydrogel FOXSEAL Vented Dressing - Chest seal dressing for open chest wounds (Swedish/ Nor Hydrogel FOXSEAL Vented Dressing - Chest seal dressing for open chest wounds (Swedish/ Norwegian/ English CE&US pack)
Catalog Number
FG08814611
Brand Name
FOXSEAL Vented
Version/Model Number
FG08814611
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
-
Product Code
NAD
Product Code Name
Dressing, Wound, Occlusive
Public Device Record Key
9703a628-1c23-41d1-8b65-015f997c78b8
Public Version Date
February 21, 2022
Public Version Number
1
DI Record Publish Date
February 11, 2022
Package DI Number
75060206631297
Quantity per Package
100
Contains DI Package
15060206631295
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| U | Unclassified | 14 |