Duns Number:025460908
Device Description: THORACOSTOMEY/CHEST TUBE TRAY
Catalog Number
CHT2035
Brand Name
Centurion Medical Products Corp
Version/Model Number
CHT2035
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
LRO
Product Code Name
General surgery tray
Public Device Record Key
d784ee7a-efd5-4106-ae3a-daff4e049bb7
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
February 06, 2022
Package DI Number
40653160992142
Quantity per Package
10
Contains DI Package
10653160992141
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 |