Duns Number:907156371
Device Description: Band Marker 5.0 - 4.5 - 4.0 - 3.5 mm
Catalog Number
75.01.007
Brand Name
Morelli
Version/Model Number
75.01.007
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
-
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
ECR
Product Code Name
SETTER, BAND, ORTHODONTIC
Public Device Record Key
71e2fb8f-c03c-4830-891f-a354fbd880c9
Public Version Date
May 24, 2021
Public Version Number
1
DI Record Publish Date
May 15, 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 |