Duns Number:315018218
Device Description: ERGOPLANT Dental Tissue Forceps, curved, 5 1/2", (140 mm), serrated, non-sterile, reusable
Catalog Number
DX055R
Brand Name
ERGOPLANT
Version/Model Number
DX055R
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
EMH
Product Code Name
FORCEPS, RONGEUR, SURGICAL
Public Device Record Key
af1e861b-54eb-4334-8dae-88c5f785c0e8
Public Version Date
July 14, 2020
Public Version Number
1
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 |