Duns Number:021717889
Device Description: Submucosal Lifting Agent
Catalog Number
M00519220
Brand Name
ORISE™ Gel
Version/Model Number
M00519220
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
PLL
Product Code Name
Submucosal injection agent
Public Device Record Key
6f00534a-cd47-4bea-9f55-17d7f449ad38
Public Version Date
August 06, 2019
Public Version Number
1
DI Record Publish Date
July 29, 2019
Package DI Number
08714729993841
Quantity per Package
10
Contains DI Package
08714729993834
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |