Duns Number:961027315
Device Description: Cardinal Health Lap Sponge 18 X 18 in. Prewashed X Ray Detectable Without Loops Softpack
Catalog Number
23250-403
Brand Name
CARDINAL HEALTH
Version/Model Number
23250-403
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
GDY
Product Code Name
GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
Public Device Record Key
35df267f-7038-4afd-8c1f-b3416ff31af6
Public Version Date
March 25, 2021
Public Version Number
2
DI Record Publish Date
January 07, 2019
Package DI Number
50885380121676
Quantity per Package
40
Contains DI Package
30885380121672
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 |