Duns Number:053187985
Device Description: B&G CURETTE DOUBLE END GR 13-14 ML, BG6 HANDLE
Catalog Number
-
Brand Name
BLUE AND GREEN
Version/Model Number
MGR13-14/BG6
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EMS
Product Code Name
Curette, Periodontic
Public Device Record Key
e07d3f4a-2c9c-40c7-b18b-781704fc76f3
Public Version Date
July 31, 2020
Public Version Number
1
DI Record Publish Date
July 23, 2020
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 | 5029 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |