Duns Number:832696038
Device Description: MCGIVNEY HEMORRHOIDAL LIGATOR NON-LATEX O BANDS FOR SU407-1 DO NOT STERILIZE 100 PER PACKA MCGIVNEY HEMORRHOIDAL LIGATOR NON-LATEX O BANDS FOR SU407-1 DO NOT STERILIZE 100 PER PACKAGE (X 100)
Catalog Number
SU407-4
Brand Name
V. Mueller
Version/Model Number
SU407-4
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
FHN
Product Code Name
Ligator, hemorrhoidal
Public Device Record Key
d3522994-0db6-4f05-bfe8-145656311065
Public Version Date
April 30, 2019
Public Version Number
4
DI Record Publish Date
October 17, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |