Duns Number:001695568
Device Description: Waterproof Transparent Dressing, all one size, 2.36 in X 2.75 in (59 mm x 69 mm)
Catalog Number
-
Brand Name
Exchange Select
Version/Model Number
614299381025
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 18, 2022
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
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
68d6f4df-5a66-4b62-8486-1256826622a7
Public Version Date
August 04, 2022
Public Version Number
2
DI Record Publish Date
July 19, 2021
Package DI Number
10614299381022
Quantity per Package
72
Contains DI Package
00614299381025
Package Discontinue Date
January 18, 2022
Package Status
Not 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 |