Duns Number:017246562
Device Description: CHEST TUBE INSERTION TRAY
Catalog Number
CHT545
Brand Name
Centurion
Version/Model Number
CHT545
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
LRP
Product Code Name
TRAY, SURGICAL
Public Device Record Key
9e2ab8f5-cc0c-4032-861b-8dcb6a7d8a41
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
January 01, 2022
Package DI Number
10653160222972
Quantity per Package
6
Contains DI Package
20653160222979
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 | 6043 |
2 | A medical device with a moderate to high risk that requires special controls. | 4077 |
U | Unclassified | 1 |