Duns Number:119193803
Device Description: offer two unique ends for a super low price - use as a vented or non-vented tip. Smooth, S offer two unique ends for a super low price - use as a vented or non-vented tip. Smooth, S-shaped end cuts provide for greater patient comfort. Disposable white plastic
Catalog Number
70-24210
Brand Name
Max-Vac Evacuator Tips Unscented
Version/Model Number
7000307
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
9a239607-ad1a-4d77-b845-611e49d4fa6c
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 18, 2018
Package DI Number
00723896009826
Quantity per Package
20
Contains DI Package
00723896009819
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 |