Duns Number:315018218
Device Description: ANATOMIC COLOURS Universal Curette, curved, 7", (175 mm), double ended, ergonomic handle, ANATOMIC COLOURS Universal Curette, curved, 7", (175 mm), double ended, ergonomic handle, peek handle, H5/33, grey, non-sterile, reusable
Catalog Number
DB390R
Brand Name
ANATOMIC COLOURS
Version/Model Number
DB390R
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
EMN
Product Code Name
SCALER, PERIODONTIC
Public Device Record Key
6dd37ffe-16c9-469b-8e7e-d0bff1da25fc
Public Version Date
September 29, 2021
Public Version Number
2
DI Record Publish Date
June 17, 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 | 11840 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7088 |
| 3 | A medical device with high risk that requires premarket approval | 37 |