Duns Number:140727624
Device Description: Centesis Procedure Tray 8F x 12cm Skater™ Safety Centesis Catheter with Air Lock Valve, wi Centesis Procedure Tray 8F x 12cm Skater™ Safety Centesis Catheter with Air Lock Valve, with Safety Devices without Lidocaine
Catalog Number
ATPT1000SPLF
Brand Name
Centesis Procedure Tray
Version/Model Number
ATPT1000SPLF
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"
-
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
OJT
Product Code Name
Aspiration Tray
Public Device Record Key
dd1784f1-31f0-4a23-985f-746781849dc8
Public Version Date
July 28, 2022
Public Version Number
1
DI Record Publish Date
July 20, 2022
Package DI Number
20886333224320
Quantity per Package
10
Contains DI Package
00886333224326
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 347 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1205 |