Duns Number:023904428
Device Description: Safety Scalpels WITH PROTECTIVE SHEATH STAINLESS STEEL BLADE - DISPOSABLE - STERILE #15
Catalog Number
-
Brand Name
McKesson
Version/Model Number
16-37215
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"
Yes
For Single-Use
Yes
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
GDX
Product Code Name
Scalpel, One-Piece
Public Device Record Key
d44de7f3-99f7-4c23-9fdc-c8885244b4b6
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
July 20, 2020
Package DI Number
20612479228232
Quantity per Package
10
Contains DI Package
10612479228228
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 870 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 422 |
| U | Unclassified | 44 |