Duns Number:015108087
Device Description: Iris 5% NAF VARNISH - Mint (200)
Catalog Number
-
Brand Name
IRIS
Version/Model Number
4323-635
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LBH
Product Code Name
Varnish, Cavity
Public Device Record Key
4d4930ae-a65a-4098-878b-d831711809a4
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 23, 2016
Package DI Number
20366975000594
Quantity per Package
14
Contains DI Package
00366975000590
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 | 1364 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 377 |
| U | Unclassified | 15 |