Duns Number:012430880
Device Description: Intended for sulcus retraction prior to impression making and to control bleeding and ging Intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative andoperative dentistry used with gingival retraction cord. It is also intended to facilitate the insertion of the cord into the sulcus.
Catalog Number
5702540
Brand Name
HSEU
Version/Model Number
5702540
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
d428b3fe-6d36-48ed-a6c2-158d9ff7c064
Public Version Date
December 06, 2021
Public Version Number
2
DI Record Publish Date
March 12, 2021
Package DI Number
20304040151444
Quantity per Package
20
Contains DI Package
10304040151447
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 |