Duns Number:017524666
Device Description: SHARD Disposable Premium Surgical Stainless Scalpels, Sterile. Size 11.
Catalog Number
A301-P11
Brand Name
SHARD
Version/Model Number
A301-P11
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
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
Yes
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
01c71f21-b131-43fe-815d-c656265378f2
Public Version Date
April 04, 2022
Public Version Number
1
DI Record Publish Date
March 25, 2022
Package DI Number
10814639024002
Quantity per Package
10
Contains DI Package
00814639024005
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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 121 |