Duns Number:119193803
Device Description: sachets help your patients practice good dental hygiene wherever they go. Each packet tear sachets help your patients practice good dental hygiene wherever they go. Each packet tears open to a tangle-free 18" strand of waxed mint nylon floss. Perfect for dispensing to patients, and for use chairside to maximize infection prevention
Catalog Number
71-23814
Brand Name
SmileGoods Indifloss Waxed Mint
Version/Model Number
NYLON MINT SACHET
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
b70c6697-cf33-4161-bd56-64c74e85dfa2
Public Version Date
August 20, 2018
Public Version Number
1
DI Record Publish Date
July 19, 2018
Package DI Number
00723896011058
Quantity per Package
20
Contains DI Package
00723896011041
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 | 93 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |