Duns Number:021717889
Device Description: Single-Use Duodenoscope
Catalog Number
-
Brand Name
EXALT™ Model D
Version/Model Number
M0054242CE0
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
-
Product Code
FDT
Product Code Name
Duodenoscope and accessories, flexible/rigid
Public Device Record Key
7a7a0faa-ffbf-4720-9cf5-162c990428d9
Public Version Date
June 15, 2020
Public Version Number
1
DI Record Publish Date
June 05, 2020
Package DI Number
08714729995753
Quantity per Package
2
Contains DI Package
08714729995746
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |