Duns Number:961027315
Device Description: Cardinal Health™ Topical Skin AdhesiveLiquidband Octyl Mini
Catalog Number
CHLOM01-04
Brand Name
CARDINAL HEALTH
Version/Model Number
CHLOM01-04
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132243,K132243,K132243
Product Code
MPN
Product Code Name
Tissue adhesive for the topical approximation of skin
Public Device Record Key
209ac17d-69b3-433d-b406-2d94a85e8ad6
Public Version Date
November 24, 2020
Public Version Number
2
DI Record Publish Date
February 28, 2019
Package DI Number
20885380167079
Quantity per Package
10
Contains DI Package
10885380167072
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 |