Duns Number:001695568
Device Description: Antibacterial Non-Stick Pads, all one size, 3 IN x 4 IN (76 mm x 101 mm). Contains: Polyhe Antibacterial Non-Stick Pads, all one size, 3 IN x 4 IN (76 mm x 101 mm). Contains: Polyhexamethylene Biguadine (PHMB) 0.2%
Catalog Number
-
Brand Name
Exchange Select
Version/Model Number
614299063389
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)
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
59d9d754-41a0-48a7-83e9-fb1dd890b04d
Public Version Date
August 31, 2020
Public Version Number
1
DI Record Publish Date
August 21, 2020
Package DI Number
10614299063386
Quantity per Package
72
Contains DI Package
00614299063389
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |