Duns Number:505942961
Device Description: The da Vinci XI Basket for SI PCF and SI PCF S (including Hose and Luer) is for some Medis The da Vinci XI Basket for SI PCF and SI PCF S (including Hose and Luer) is for some Medisafe and InnoWave SI PCF and SI PCF S washer disinfectors.
Catalog Number
IW1038
Brand Name
NA
Version/Model Number
MP21104
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
-
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
MEC
Product Code Name
Disinfector, medical devices
Public Device Record Key
7673524b-1423-422e-b865-137d316f142a
Public Version Date
March 22, 2021
Public Version Number
1
DI Record Publish Date
March 12, 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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |