Duns Number:027680821
Device Description: Intended to remove surgical residue from surgical instruments and endoscopic devices after Intended to remove surgical residue from surgical instruments and endoscopic devices after surgical procedures
Catalog Number
-
Brand Name
SafeClean ® Scope Channel Cleaning Brush
Version/Model Number
248105BBG
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
d344c8d2-4abb-434a-b1e0-a4ac7c196ed3
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
March 28, 2021
Package DI Number
10840113206817
Quantity per Package
50
Contains DI Package
00840113206810
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 | 952 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 494 |