Duns Number:025460908
Device Description: STERILE MALLET ORTHO 16 OZ 10.5 IN
Catalog Number
SM501573
Brand Name
MEDLINE
Version/Model Number
SM501573
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
KDC
Product Code Name
INSTRUMENT, SURGICAL, DISPOSABLE
Public Device Record Key
ec1b451d-5df7-46e2-b060-f8a2cceb8776
Public Version Date
June 17, 2022
Public Version Number
2
DI Record Publish Date
January 02, 2022
Package DI Number
20888277701417
Quantity per Package
8
Contains DI Package
10888277701410
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |