Duns Number:096372255
Device Description: #11 Safety Scalpel
Catalog Number
D4511
Brand Name
DeRoyal
Version/Model Number
D4511
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
GDZ
Product Code Name
HANDLE, SCALPEL
Public Device Record Key
8d94f5dd-b9f7-4a44-af73-c63f749c3af1
Public Version Date
July 19, 2021
Public Version Number
1
DI Record Publish Date
July 09, 2021
Package DI Number
30749756150584
Quantity per Package
25
Contains DI Package
00749756150583
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 | 7041 |
2 | A medical device with a moderate to high risk that requires special controls. | 4913 |
U | Unclassified | 3 |