Duns Number:591592316
Device Description: 1 x Channel cleaning brush, channel ID 2.8-5.0mm, length 2200mm, 5x 360 degree wipers.1 x 1 x Channel cleaning brush, channel ID 2.8-5.0mm, length 2200mm, 5x 360 degree wipers.1 x Port cleaning brush, double head, 5mm and 12mm.
Catalog Number
ZZ2850+1+SPUP+2200
Brand Name
PULL THRU™ Cleaning Brush
Version/Model Number
ZZ2850+1+SPUP+2200 Single patient pack
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
72ed3189-3e80-485d-bcd9-eff074a664b4
Public Version Date
October 20, 2022
Public Version Number
1
DI Record Publish Date
October 12, 2022
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 | 8 |