Duns Number:023904428
Device Description: Scalpel Blades STAINLESS STEEL DISPOSABLE #15
Catalog Number
-
Brand Name
McKesson
Version/Model Number
1642
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
GES
Product Code Name
Blade, Scalpel
Public Device Record Key
cdbcddce-1d1c-4546-b896-c805265c4c21
Public Version Date
January 22, 2021
Public Version Number
3
DI Record Publish Date
July 20, 2020
Package DI Number
40612479206203
Quantity per Package
50
Contains DI Package
20612479206193
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
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 |