Duns Number:825137818
Device Description: Air/Water Syringe Crystal Tip & Flash Tip
Catalog Number
9528890
Brand Name
Darby Dental Supply, LLC
Version/Model Number
9528890
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
ECB
Product Code Name
UNIT, SYRINGE, AIR AND/OR WATER
Public Device Record Key
b2468393-b725-4d1c-8cc5-d0813d9c0cc1
Public Version Date
June 13, 2019
Public Version Number
1
DI Record Publish Date
June 05, 2019
Package DI Number
20889813024601
Quantity per Package
40
Contains DI Package
00889813024607
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 | 1457 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 194 |
| U | Unclassified | 2 |