Duns Number:989891457
Device Description: 2 Ampoules, 10 mL each. To facilitate endoscopic resection procedures. For sample use only 2 Ampoules, 10 mL each. To facilitate endoscopic resection procedures. For sample use only, not for resale.
Catalog Number
-
Brand Name
Eleview
Version/Model Number
9000008
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"
Yes
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
e7de8094-d3a0-46c7-a5d1-c47c5cb24261
Public Version Date
December 27, 2019
Public Version Number
1
DI Record Publish Date
December 19, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |