Duns Number:961027315
Device Description: Butyl Topical Skin Adhesive, Precision Tip Clear, 0.5mL
Catalog Number
LFC004
Brand Name
CARDINAL HEALTH
Version/Model Number
LFC004
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2017
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
K122446,K122446,K122446
Product Code
MPN
Product Code Name
Tissue adhesive for the topical approximation of skin
Public Device Record Key
f9a11169-7a52-4e79-b329-2bbf464c009b
Public Version Date
July 17, 2018
Public Version Number
4
DI Record Publish Date
August 15, 2016
Package DI Number
50885380109773
Quantity per Package
6
Contains DI Package
20885380109772
Package Discontinue Date
December 31, 2017
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 | 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 |