Duns Number:008124539
Device Description: Dyna Stopper Trauma Dressing, Sterile, 60/cs; Open- 9"x5 1/2"; Folded- 3 1/2"x5 1/2"; Mult Dyna Stopper Trauma Dressing, Sterile, 60/cs; Open- 9"x5 1/2"; Folded- 3 1/2"x5 1/2"; Multi-purpose wound and trauma dressing
Catalog Number
-
Brand Name
Dyna Stopper Trauma Dressing
Version/Model Number
3535
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FQM
Product Code Name
Bandage, Elastic
Public Device Record Key
5c3f6e2c-1b76-47bb-b1d7-7eac2f7e99aa
Public Version Date
December 08, 2021
Public Version Number
2
DI Record Publish Date
June 21, 2021
Package DI Number
00616784353531
Quantity per Package
60
Contains DI Package
00616784353517
Package Discontinue Date
-
Package Status
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 | 694 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |
| 3 | A medical device with high risk that requires premarket approval | 2 |