Duns Number:025460908
Device Description: GENERAL ENT TRAY
Catalog Number
MNS13685
Brand Name
Centurion Medical Products Corp
Version/Model Number
MNS13685
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
OGR
Product Code Name
Ear, nose, and throat surgical tray
Public Device Record Key
a3875ee3-12b5-4f1b-a957-4d9989dd290f
Public Version Date
July 25, 2022
Public Version Number
1
DI Record Publish Date
July 17, 2022
Package DI Number
40653160992616
Quantity per Package
24
Contains DI Package
10653160992615
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 |