Duns Number:006961700
Device Description: FLSP CNT MNT HT 90
Catalog Number
-
Brand Name
Up&Up
Version/Model Number
7A7
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
ec2011e2-c07d-4da0-87db-b7e585fddbcc
Public Version Date
January 30, 2020
Public Version Number
1
DI Record Publish Date
January 22, 2020
Package DI Number
10071031450529
Quantity per Package
72
Contains DI Package
00071031450522
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 22 |
2 | A medical device with a moderate to high risk that requires special controls. | 52 |
U | Unclassified | 12 |