Duns Number:078352849
Device Description: Tatum Scalpel Handle RH Offset - Attaches to scalpel blade (not included) - to hold blade Tatum Scalpel Handle RH Offset - Attaches to scalpel blade (not included) - to hold blade during cutting or dissection of tissue
Catalog Number
Scalpel Handle-SB-R
Brand Name
Tatum Scalpel Handle RH Offset
Version/Model Number
Tatum Offset Scalpel Handle (Right) SB-R
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
67e28c61-fd7c-4f13-9bb5-cbc95d282505
Public Version Date
February 10, 2021
Public Version Number
1
DI Record Publish Date
February 02, 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 |