Duns Number:315018218
Device Description: ERGOPLANT Tunneling Instrument, straight, 7 3/4", (195 mm), ERGOPLANT, non-sterile, reusab ERGOPLANT Tunneling Instrument, straight, 7 3/4", (195 mm), ERGOPLANT, non-sterile, reusable
Catalog Number
DX310R
Brand Name
ERGOPLANT
Version/Model Number
DX310R
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
DZN
Product Code Name
INSTRUMENTS, DENTAL HAND
Public Device Record Key
4558f29e-f45b-4979-93b6-9d6446a9ca6b
Public Version Date
September 29, 2021
Public Version Number
2
DI Record Publish Date
July 06, 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 |