Duns Number:961027315
Device Description: X-Ray Detectable Sponges 4 x 8in. (10.2 x 20.3cm)12-Ply Woven 100 percent Cotton With Wa X-Ray Detectable Sponges 4 x 8in. (10.2 x 20.3cm)12-Ply Woven 100 percent Cotton With WavyBarium Sulfate Band CAUTION: For External UseOnly. Non Sterile. Single Use Only. Not Made withNatural Rubber Latex. Store in a Cool, Dry Place.
Catalog Number
C-NXR4812
Brand Name
CARDINAL HEALTH
Version/Model Number
C-NXR4812
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
NAB
Product Code Name
Gauze / sponge,nonresorbable for external use
Public Device Record Key
d95c069d-8aaa-4e09-8bbe-472f6163c8e2
Public Version Date
June 27, 2019
Public Version Number
1
DI Record Publish Date
June 19, 2019
Package DI Number
50885380130937
Quantity per Package
20
Contains DI Package
20885380130936
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 |