Duns Number:046601986
Device Description: SmartBand EMR Ligator Pack (12mm) is indicated for endoscopic mucosal resection in the up SmartBand EMR Ligator Pack (12mm) is indicated for endoscopic mucosal resection in the upper GI tract and offers a reloadable barrel of bands for procedures requiring more than 5 bands.
Catalog Number
SBEMRP12
Brand Name
SmartBand EMR Pack
Version/Model Number
SBEMRP12
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
K212860
Product Code
FDI
Product Code Name
SNARE, FLEXIBLE
Public Device Record Key
ae5e37a8-dfc7-4422-aecb-3c63ec89ab45
Public Version Date
March 29, 2022
Public Version Number
1
DI Record Publish Date
March 21, 2022
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. | 11 |