Duns Number:012676012
Device Description: VacuCord knitted gingival non-medicated retraction cord for rapid tissue displacement and VacuCord knitted gingival non-medicated retraction cord for rapid tissue displacement and absorption of fluid at the sulcusSize 0, 100"
Catalog Number
-
Brand Name
VacCord Gingival Retraction Cord
Version/Model Number
Size 0
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JES
Product Code Name
Floss, Dental
Public Device Record Key
61061e79-614c-4aef-b5ee-a6c87e3aa180
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 11, 2017
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 | 5 |