Duns Number:961027315
Device Description: Polyester Fiber Tipped Applicators, 6in. L
Catalog Number
A5005-1
Brand Name
CARDINAL HEALTH
Version/Model Number
A5005-1
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
KXG
Product Code Name
APPLICATOR, ABSORBENT TIPPED, STERILE
Public Device Record Key
9611f276-b281-43ec-aba5-7075d336ec14
Public Version Date
January 08, 2021
Public Version Number
4
DI Record Publish Date
January 02, 2019
Package DI Number
50885380020955
Quantity per Package
10
Contains DI Package
20885380020954
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 |