Duns Number:078352849
Device Description: This is a hand-held, manual, dental surgical instrument intended to be used as a lever dur This is a hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots.
Catalog Number
Elevator Back Winged EX W5B 501
Brand Name
Zoll, Back Action Winged Elevator
Version/Model Number
Back Action Winged Elevator EXW5B 501
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
41bc0eb4-a368-4064-8cf8-a28296c97109
Public Version Date
April 15, 2022
Public Version Number
1
DI Record Publish Date
April 07, 2022
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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |