Duns Number:623191194
Device Description: Health-Tec/DHP Air/Water Syringe Tips Assorted Colors Plastic Core 250/bag
Catalog Number
540-HT250A
Brand Name
Health-Tec/DHP Air/Water Syringe Tips
Version/Model Number
540-HT250A
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
-
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
31902307-fe50-4c2a-a941-46316f976447
Public Version Date
October 24, 2022
Public Version Number
1
DI Record Publish Date
October 14, 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 |