Duns Number:243137838
Device Description: A case containing 20 Individually sealed kits, each kit containing one ligator with obtura A case containing 20 Individually sealed kits, each kit containing one ligator with obturator, a bag of 3 latex bands, a loading cone and a patient brochure.
Catalog Number
11-4120
Brand Name
CRH O'Regan System
Version/Model Number
11-4120
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
FHN
Product Code Name
Ligator, Hemorrhoidal
Public Device Record Key
117c9ae9-f181-4220-a616-d427d5fef7a9
Public Version Date
October 09, 2020
Public Version Number
1
DI Record Publish Date
October 01, 2020
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. | 1 |