Duns Number:243872611
Device Description: Customized single Use Anorectal 8 Channel Catheter
Catalog Number
-
Brand Name
Mui Scientific
Version/Model Number
S7-R8-1086
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K823701,K823701
Product Code
FFX
Product Code Name
System, Gastrointestinal Motility (Electrical)
Public Device Record Key
21a5cdc3-a601-4c30-a534-ca3db124ef73
Public Version Date
August 05, 2022
Public Version Number
3
DI Record Publish Date
April 10, 2019
Package DI Number
10678467506730
Quantity per Package
10
Contains DI Package
00678467506733
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 963 |