Duns Number:009260217
Device Description: Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, siz Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, size 10/2
Catalog Number
07820
Brand Name
Racord Two Retraction Cord 10/2
Version/Model Number
07820
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 22, 2021
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
Yes
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
882a2725-7b4d-4e8b-81ef-2e78cb5b68cd
Public Version Date
November 23, 2021
Public Version Number
2
DI Record Publish Date
January 24, 2019
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 | 34 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6 |
| U | Unclassified | 57 |