Duns Number:305088619
Device Description: Rat Tooth Alligator Grasper intended for hysteroscopy and cystoscopy. Minimum channel diam Rat Tooth Alligator Grasper intended for hysteroscopy and cystoscopy. Minimum channel diameter: Ø2.0mm.
Catalog Number
OP-GRA-6
Brand Name
LiNA OperaScope™ Rat Tooth Alligator Grasper
Version/Model Number
OP-GRA-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
HTD
Product Code Name
Forceps
Public Device Record Key
591f68e2-5f99-4947-bc37-a27008bbe1e0
Public Version Date
September 14, 2020
Public Version Number
1
DI Record Publish Date
September 04, 2020
Package DI Number
05708265012473
Quantity per Package
6
Contains DI Package
05708265012466
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| 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 |