Duns Number:078352849
Device Description: Scalpel Removers, Curved Tip, Tungsten Carbide Tip. To grip and remove Scalpel blades safe Scalpel Removers, Curved Tip, Tungsten Carbide Tip. To grip and remove Scalpel blades safely from patient and or from scalpel handles.
Catalog Number
Scalpel Remover T/C
Brand Name
Scalpel Remover
Version/Model Number
Scalpel Remover T/C
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
0a743bd6-d3f4-4d03-8532-5caf207c61a9
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
August 06, 2021
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 |