Duns Number:025460908
Device Description: URETHRAL CATHETER TRAY
Catalog Number
CC520
Brand Name
Centurion Medical Products Corp
Version/Model Number
CC520
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OIB
Product Code Name
Blood and urine collection kit (excludes HIV testing)
Public Device Record Key
bfef0cdf-efe8-47e6-ad82-7876ca39ce6f
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
September 02, 2021
Package DI Number
40653160064696
Quantity per Package
15
Contains DI Package
10653160064695
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |