Duns Number:961394798
Device Description: Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small is designed to detect a br Brush for VERIFY RESI-TEST SLIDE-THRU Cleaning Indicator, Small is designed to detect a broad spectrum of protein residues and is intended for use after manual or automated cleaning and prior to high level disinfection or sterilization.
Catalog Number
2D73QH
Brand Name
VERIFY
Version/Model Number
Resi-Test
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)
Yes
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
9210625f-ae29-4394-9c2d-79d5b94e5137
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
May 25, 2022
Package DI Number
10724995216563
Quantity per Package
25
Contains DI Package
00724995216566
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1528 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1557 |