Duns Number:012430880
Device Description: Dental Floss
Catalog Number
1554658
Brand Name
Henry Schein
Version/Model Number
1554658
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)
Yes
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
ab3fa825-35bc-45a9-b772-aa21b6cb4f69
Public Version Date
February 25, 2019
Public Version Number
1
DI Record Publish Date
January 25, 2019
Package DI Number
20304040036680
Quantity per Package
6
Contains DI Package
10304040036683
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 |