Duns Number:961027315
Device Description: PLAIN PACKING STRIP 1/4INX5YD, STER
Catalog Number
C-PG145P
Brand Name
CARDINAL HEALTH
Version/Model Number
C-PG145P
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
EFQ
Product Code Name
GAUZE/SPONGE, INTERNAL
Public Device Record Key
06c7889d-2ce5-4d9a-a9fa-320bc77f6e0e
Public Version Date
June 19, 2020
Public Version Number
2
DI Record Publish Date
May 29, 2019
Package DI Number
50885380052215
Quantity per Package
12
Contains DI Package
10885380052217
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 |