Duns Number:025217003
Catalog Number
-
Brand Name
BLDG Active
Version/Model Number
1403
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
-
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
K150799,K150799
Product Code
FRO
Product Code Name
Dressing, Wound, Drug
Public Device Record Key
1599a698-3b29-4ef5-a619-4ba04ba45947
Public Version Date
October 28, 2022
Public Version Number
1
DI Record Publish Date
October 20, 2022
Package DI Number
10818582012420
Quantity per Package
6
Contains DI Package
00818582012423
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
U | Unclassified | 20 |