Duns Number:626406016
Device Description: Dental restorative material canula, single-use
Catalog Number
032110
Brand Name
Large (White) Intraoral Tips
Version/Model Number
032110
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
EID
Product Code Name
SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL
Public Device Record Key
e0981a67-f1e9-4885-8972-95c0763c0610
Public Version Date
March 25, 2020
Public Version Number
1
DI Record Publish Date
March 17, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1461 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 234 |
| U | Unclassified | 6 |