Duns Number:012430880
Device Description: An aqueous based 15.5% Ferric Sulfate solution, which is excellent for soaking retraction An aqueous based 15.5% Ferric Sulfate solution, which is excellent for soaking retraction cord, eliminating sulcular fluid contamination, aiding gingival retraction and reducing mucous membrane inflammation.
Catalog Number
5702546
Brand Name
HSEU
Version/Model Number
5702546
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
-
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
MVL
Product Code Name
CORD, RETRACTION
Public Device Record Key
1206a3de-42be-4488-a9f9-4e06cc118084
Public Version Date
December 06, 2021
Public Version Number
2
DI Record Publish Date
March 12, 2021
Package DI Number
20304040151383
Quantity per Package
20
Contains DI Package
10304040151386
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |