Duns Number:448015938
Device Description: Helioseal Clear syringes, Helioseal Clear cannulas 0.4mm, Email Preparator blue, Email Pre Helioseal Clear syringes, Helioseal Clear cannulas 0.4mm, Email Preparator blue, Email Preparator cannulas
Catalog Number
558520AN
Brand Name
Helioseal
Version/Model Number
558520AN
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 26, 2022
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
-
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
EBC
Product Code Name
SEALANT, PIT AND FISSURE, AND CONDITIONER
Public Device Record Key
1d7bc81d-a595-411f-bf2d-9decd4e7bcff
Public Version Date
January 27, 2022
Public Version Number
2
DI Record Publish Date
September 25, 2018
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 | 131 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12768 |