Duns Number:119193803
Device Description: combine the patented comfort of a soft elastic tip with bold bright colored tubing. Superi combine the patented comfort of a soft elastic tip with bold bright colored tubing. Superior Italian-quality construction holds a bend without kinking. Fixed clear ends. 6” long. Phthalate-free.
Catalog Number
70-19116 BLU
Brand Name
Total-Comfort ColorFlex Soft Tip Aspirators Blue
Version/Model Number
70-19116 BLU
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EHZ
Product Code Name
Evacuator, Oral Cavity
Public Device Record Key
4b5e14f5-65c7-44df-88df-c6dc464d3e65
Public Version Date
August 13, 2018
Public Version Number
1
DI Record Publish Date
July 12, 2018
Package DI Number
00723896009598
Quantity per Package
10
Contains DI Package
00723896009581
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |