Duns Number:623191194
Device Description: Health-Tec/DHP Luer Lock Syringes 3cc with 27ga Irrigation Needle 100/box
Catalog Number
130-10007
Brand Name
Health-Tec/DHP Syringes with Needle
Version/Model Number
130-10007
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EIC
Product Code Name
Syringe, Periodontic, Endodontic, Irrigating
Public Device Record Key
6b17c3dc-64ed-4756-ae25-a5ea880966cf
Public Version Date
October 27, 2022
Public Version Number
1
DI Record Publish Date
October 19, 2022
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 | 464 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 78 |