Duns Number:008162518
Device Description: Ortho Mallet 11", 2lb 2oz [964g], head s/s Ø 35mm, s/s hdl l
Catalog Number
gS 59.7660
Brand Name
gSource
Version/Model Number
gS 59.7660
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GFJ
Product Code Name
Mallet, Surgical, General & Plastic Surgery
Public Device Record Key
7c72b3e9-af45-45de-b8e9-9a4bdfd1e976
Public Version Date
August 29, 2022
Public Version Number
3
DI Record Publish Date
February 14, 2020
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 | 4617 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 280 |