Duns Number:140727624
Device Description: Centesis Procedure Tray 8F x 16cm Skater™ Safety Centesis Catheter with Pigtail and Blunt Centesis Procedure Tray 8F x 16cm Skater™ Safety Centesis Catheter with Pigtail and Blunt Retracting Stylet, with Safety Devices
Catalog Number
APIG1280TSP
Brand Name
Centesis Procedure Tray
Version/Model Number
APIG1280TSP
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
2e8933b4-c1a0-40f3-b822-c4e89655ad32
Public Version Date
July 28, 2022
Public Version Number
1
DI Record Publish Date
July 20, 2022
Package DI Number
20886333220926
Quantity per Package
10
Contains DI Package
00886333220922
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 |