Duns Number:961027315
Device Description: FABRIC ADHESIVE BANDAGE XL 2X4IN,ST
Catalog Number
C-BDF24XL
Brand Name
CARDINAL HEALTH
Version/Model Number
C-BDF24XL
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
KGX
Product Code Name
Tape and bandage, adhesive
Public Device Record Key
7cec2399-e926-4a68-be53-97aede89729a
Public Version Date
August 07, 2020
Public Version Number
3
DI Record Publish Date
April 17, 2019
Package DI Number
50885380052499
Quantity per Package
12
Contains DI Package
20885380052498
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |