Duns Number:907156371
Device Description: Extrarradicular Orthodontic Steel Mini Screw (Leng.: 5mm - Transm.: 4mm - Ø2mm)
Catalog Number
37.10.405
Brand Name
Morelli
Version/Model Number
37.10.405
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
OAT
Product Code Name
Implant, endosseous, orthodontic
Public Device Record Key
7c13f431-b901-4c89-8b99-c4db259daa29
Public Version Date
May 11, 2021
Public Version Number
1
DI Record Publish Date
May 03, 2021
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 | 1414 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 87 |