Duns Number:989891457
Device Description: A sterile solution intended to be injected via an endoscopic injection needle into the sub A sterile solution intended to be injected via an endoscopic injection needle into the submucosal layer of the gastrointestinal tract to facilitate excision of mucosal lesions (e.g. polyps, adenomas, early cancers) by lifting the mucosa over a bubble of fluid. it is typically a gel-like substance containing an emulsion of fats and salts, and may include a dye. This is a single-use device.
Catalog Number
-
Brand Name
Eleview
Version/Model Number
CB-17-04
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
deac0eae-2137-4a79-bdca-29afa8131511
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 10, 2017
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 |