Duns Number:040729840
Device Description: Stainless Steel Head for Mallet 1.0 Inch 1100-462S
Catalog Number
-
Brand Name
Stainless Steel Head for Mallet
Version/Model Number
1100-462SH
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
-
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
HXL
Product Code Name
MALLET
Public Device Record Key
8af80289-6383-41ba-959c-bf955e9fcc45
Public Version Date
April 16, 2021
Public Version Number
1
DI Record Publish Date
April 08, 2021
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 | 10108 |
2 | A medical device with a moderate to high risk that requires special controls. | 3414 |