Duns Number:160990313
Device Description: Submucosal Lifting Agent - 5mL Single Unit
Catalog Number
GIS-55
Brand Name
EverLift
Version/Model Number
GIS-55
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
K191923,K191923
Product Code
PLL
Product Code Name
Submucosal Injection Agent
Public Device Record Key
6c1966a9-38f0-437f-9088-4b97bbd7d9d0
Public Version Date
February 26, 2021
Public Version Number
1
DI Record Publish Date
February 18, 2021
Package DI Number
10893029002226
Quantity per Package
10
Contains DI Package
00893029002229
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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |