Duns Number:305088619
Device Description: Alligator Biopsy Forceps for hysteroscopy. Minimum channel diameter: Ø2.0mm.
Catalog Number
OP-FCP-6
Brand Name
LiNA OperaScope™ Biopsy Forceps
Version/Model Number
OP-FCP-6
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
NWW
Product Code Name
Hysteroscope Accessories
Public Device Record Key
7e454e86-f866-4dcf-9391-1fbe1ef5c8c7
Public Version Date
August 21, 2019
Public Version Number
2
DI Record Publish Date
April 11, 2018
Package DI Number
05708265010189
Quantity per Package
6
Contains DI Package
05708265010172
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 |