Duns Number:305682023
Device Description: aScope Duodeno (box of 4 pcs)
Catalog Number
482001000/4
Brand Name
aScope™ Duodeno
Version/Model Number
482001000/4
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K201098,K201098
Product Code
FDT
Product Code Name
Duodenoscope and accessories, flexible/rigid
Public Device Record Key
890b3fa1-6254-435d-970e-6b7bab96d055
Public Version Date
April 27, 2022
Public Version Number
1
DI Record Publish Date
April 19, 2022
Package DI Number
05707480157426
Quantity per Package
4
Contains DI Package
05707480157402
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 309 |