Duns Number:030650113
Device Description: Lasso Polypectomy Snare
Catalog Number
1180-11
Brand Name
Lasso
Version/Model Number
1180-11
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)
Yes
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
FDI
Product Code Name
Snare, Flexible
Public Device Record Key
624efc9d-e96f-47c7-9388-b88917ad3306
Public Version Date
March 22, 2019
Public Version Number
3
DI Record Publish Date
November 16, 2018
Package DI Number
10816734021610
Quantity per Package
10
Contains DI Package
00816734021613
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 109 |
2 | A medical device with a moderate to high risk that requires special controls. | 207 |