Duns Number:119193803
Device Description: Hard plastic tip saliva ejectors are just that-hard! They pinch lingual surfaces, jab the Hard plastic tip saliva ejectors are just that-hard! They pinch lingual surfaces, jab the mandible and aspirate tender tissue. Here is a truly comfortable solution-so comfortable, it's patented!Total-Comfort Soft Tip Aspirators feature cushioned, flexible, patient-friendly tips. Tested and proven to be gentle on soft tissue and bone while reducing soft tissue aspiration. Elastic tips are securely bonded for safety. 100% non-latex. 6" long. 100 aspirators per bag with white or clear tubing.
Catalog Number
70-24910 WHI
Brand Name
Total-Comfort Blue Soft Tip Aspirators White Tubing
Version/Model Number
K2900-BAS155TC
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
5c5eee2b-72e2-467a-a284-f0b0c88febf2
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896009864
Quantity per Package
10
Contains DI Package
00723896009857
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 |