Duns Number:160990313
Device Description: The GI Supply Large Volume Paracentesis Kit
Catalog Number
GIS-28
Brand Name
Large Volume Paracentesis Kit
Version/Model Number
GIS-28
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 03, 2018
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
K970187,K970187
Product Code
LRO
Product Code Name
General Surgery Tray (Kit)
Public Device Record Key
e90af11a-1fc1-4e93-8a79-75ad64feaa5c
Public Version Date
July 07, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
10893029002004
Quantity per Package
5
Contains DI Package
00893029002007
Package Discontinue Date
August 03, 2018
Package Status
Not 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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |