Duns Number:078352849
Device Description: Tatum Scalpel Handle - Attaches to scalpel blade (not included) - to hold blade during cut Tatum Scalpel Handle - Attaches to scalpel blade (not included) - to hold blade during cutting or dissection of tissue
Catalog Number
Scalpel Handle
Brand Name
Tatum Scalpel Handle
Version/Model Number
Scalpel Handle
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
3d2ff553-5b6c-4c87-bff8-14da48808de6
Public Version Date
February 03, 2021
Public Version Number
2
DI Record Publish Date
December 04, 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 | 405 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 536 |