Duns Number:044668515
Device Description: COSMETIC SIERRA CLASSIC UR CUSPID 022 T=0 A+11 R4M W/HK DIST
Catalog Number
002-9541MH
Brand Name
Sierra Classic
Version/Model Number
002-9541MH
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2017
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
DYW
Product Code Name
BRACKET, PLASTIC, ORTHODONTIC
Public Device Record Key
ca39f677-d44c-494f-897c-b456dbe01aaa
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 24, 2016
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 | 16634 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 982 |