Duns Number:315018218
Device Description: ERGOPLANT Sinus Elevator, 7 7/8", (200 mm), non-sterile, reusable
Catalog Number
DX560R
Brand Name
ERGOPLANT
Version/Model Number
DX560R
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
EMJ
Product Code Name
ELEVATOR, SURGICAL, DENTAL
Public Device Record Key
6331e524-35f5-44ea-b5a2-74bcf49d61c6
Public Version Date
July 07, 2020
Public Version Number
1
DI Record Publish Date
June 29, 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 |