Duns Number:305088619
Device Description: The LiNA OperaScopeTM Lasso is intended for use in hysteroscopy procedures.
Catalog Number
OP-LAS10-3
Brand Name
LiNA OperaScope™ Lasso
Version/Model Number
OP-LAS10-3
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
GAE
Product Code Name
Snare, Surgical
Public Device Record Key
a378ca56-cdb2-45ab-9a50-716e8547d8e2
Public Version Date
September 03, 2019
Public Version Number
1
DI Record Publish Date
August 26, 2019
Package DI Number
05708265011520
Quantity per Package
3
Contains DI Package
05708265011513
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 | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |