Duns Number:481233849
Device Description: Double Suction Bags set
Catalog Number
M0068402060
Brand Name
LITHOCLAST
Version/Model Number
DT-486
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
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
d54433e5-3434-4d08-ba0d-27bf7747ffed
Public Version Date
September 12, 2018
Public Version Number
2
DI Record Publish Date
March 12, 2018
Package DI Number
07613353132118
Quantity per Package
5
Contains DI Package
07613353132125
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 | 226 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| 3 | A medical device with high risk that requires premarket approval | 11 |