Duns Number:961027315
Device Description: -Thin Hydrocolloid 1.75x1.5in. Spot Dressing
Catalog Number
HCTSPOTS
Brand Name
CARDINAL HEALTH
Version/Model Number
HCTSPOTS
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
NAD
Product Code Name
Dressing, wound, occlusive
Public Device Record Key
a3483221-d790-4052-8ed1-483087269e73
Public Version Date
July 22, 2021
Public Version Number
4
DI Record Publish Date
May 29, 2019
Package DI Number
00888499000776
Quantity per Package
10
Contains DI Package
70888499000775
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |