Duns Number:082779828
Device Description: Endoscopy Procedure Kit
Catalog Number
345CKENT
Brand Name
Ruhof Scope Valet Custom Kit
Version/Model Number
345CKENT
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
-
Product Code
MNL
Product Code Name
Accessories, Cleaning Brushes, For Endoscope
Public Device Record Key
e66efba1-54b9-4d16-86b9-abcd8eb6d0a4
Public Version Date
June 27, 2022
Public Version Number
1
DI Record Publish Date
June 17, 2022
Package DI Number
10810929044873
Quantity per Package
12
Contains DI Package
00810929044876
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 1 |