Duns Number:025460908
Device Description: PERCUTANEOUS CATHETER PLCMNT
Catalog Number
MNS6985B
Brand Name
Centurion Medical Products Corp
Version/Model Number
MNS6985B
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
OES
Product Code Name
Cardiac catheterization kit
Public Device Record Key
61a27281-7810-4d77-9e12-86ed814a11f7
Public Version Date
July 11, 2022
Public Version Number
1
DI Record Publish Date
July 03, 2022
Package DI Number
40653160993262
Quantity per Package
16
Contains DI Package
10653160993261
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 |