Duns Number:017246562
Device Description: ST LABORDE TRACHEA DILATOR 5.5'
Catalog Number
I68895
Brand Name
Centurion
Version/Model Number
I68895
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
KDC
Product Code Name
INSTRUMENT, SURGICAL, DISPOSABLE
Public Device Record Key
2e69eaa3-4130-4882-9392-b7b8ee9e9aa9
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
February 04, 2022
Package DI Number
00653160348651
Quantity per Package
20
Contains DI Package
10653160348658
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 |