Duns Number:057728685
Device Description: Surgical Aspirator Tips, White–Standard Tip, 0.125”, 0.32 cm
Catalog Number
-
Brand Name
Surgical Aspirator Tips
Version/Model Number
ZSAWH
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
60cc0f3b-e44c-4710-b3c3-a539ddf2fd2b
Public Version Date
October 07, 2022
Public Version Number
1
DI Record Publish Date
September 29, 2022
Package DI Number
50732224000799
Quantity per Package
25
Contains DI Package
10732224000791
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 | 33 |
2 | A medical device with a moderate to high risk that requires special controls. | 25 |