Duns Number:009831413
Device Description: PRO ADVANTAGE WOUND CLOSURE BUTTERFLY MD 100/BX 12BX/CS
Catalog Number
P150105
Brand Name
PRO ADVANTAGE
Version/Model Number
P150105
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
05137a37-1f66-4ef6-9790-93a2d209f34a
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
September 23, 2018
Package DI Number
M220P1501055
Quantity per Package
1200
Contains DI Package
M220P1501053
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 224 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 192 |