Duns Number:603160040
Catalog Number
SPPT-6F-10L
Brand Name
Safety Paracentesis Procedure Tray
Version/Model Number
00884450277560
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OJV
Product Code Name
Single use instrument tray
Public Device Record Key
15b4a5c2-b648-49ff-8b3f-40f9700db13c
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
September 13, 2018
Package DI Number
10884450277567
Quantity per Package
5
Contains DI Package
00884450277560
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 573 |
2 | A medical device with a moderate to high risk that requires special controls. | 8779 |