Duns Number:091449079
Device Description: 3D Contact Dressing 4in x 8in
Catalog Number
-
Brand Name
TheraBond 3D antimicrobial barrier systems
Version/Model Number
3DAC-48
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
fc59e0be-7181-457c-847c-81576d0d31fa
Public Version Date
October 08, 2020
Public Version Number
1
DI Record Publish Date
September 30, 2020
Package DI Number
10856040008059
Quantity per Package
5
Contains DI Package
00856040008052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 13 |
U | Unclassified | 100 |