Duns Number:002212793
Device Description: MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE, 100 RINGS AND ANGLED FORCEPS. (Caution: T MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE, 100 RINGS AND ANGLED FORCEPS. (Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions)
Catalog Number
-
Brand Name
ESI
Version/Model Number
37-0810C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
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
0f942e51-4a06-4993-8b46-f38e163457e3
Public Version Date
September 18, 2019
Public Version Number
3
DI Record Publish Date
September 22, 2016
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. | 113 |