Duns Number:711789789
Catalog Number
-
Brand Name
Air/Water Channel Cleaning Adapter
Version/Model Number
MD-743
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 10, 2022
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K021886
Product Code
FDS
Product Code Name
Gastroscope and accessories, flexible/rigid
Public Device Record Key
b0434214-d2f1-4894-8e75-0d7a9b376fd2
Public Version Date
August 11, 2022
Public Version Number
11
DI Record Publish Date
September 21, 2016
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 | 117 |
2 | A medical device with a moderate to high risk that requires special controls. | 1962 |
U | Unclassified | 52 |