Duns Number:432167294
Device Description: EXORAL FACEBOWS 045 LOOPS LONG n. 2
Catalog Number
M4805P021
Brand Name
LEONE SPA
Version/Model Number
M4805P021
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
DZB
Product Code Name
Headgear, Extraoral, Orthodontic
Public Device Record Key
8721cfd0-d7e5-4227-be9b-a8823327a3a6
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 25, 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 | 6976 |
2 | A medical device with a moderate to high risk that requires special controls. | 689 |