Duns Number:315304071
Device Description: CLEANING BRUSH Ø 0.85MM TL 1200MM For flexible endoscopes with instrument channel Ø 0,8mm CLEANING BRUSH Ø 0.85MM TL 1200MM For flexible endoscopes with instrument channel Ø 0,8mm, brush length 10mm, PACK=10 PCS, color blue, for single use
Catalog Number
7990003
Brand Name
NA
Version/Model Number
7990003
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
da10da53-e09b-4705-8238-08f8b16ec06a
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 05, 2021
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 | 587 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1835 |