Duns Number:187129135
Device Description: Cartridge set with probe.
Catalog Number
-
Brand Name
Suction Irrigation Cartridge Set
Version/Model Number
C7100
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 19, 2018
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"
Yes
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
BTA
Product Code Name
Pump, Portable, Aspiration (Manual Or Powered)
Public Device Record Key
2323e1e5-7602-439e-bd81-71bc3ef5bbd4
Public Version Date
April 23, 2019
Public Version Number
6
DI Record Publish Date
August 18, 2016
Package DI Number
10607915127586
Quantity per Package
12
Contains DI Package
00607915127589
Package Discontinue Date
April 19, 2018
Package Status
Not 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 | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |