Duns Number:832696038
Device Description: ORTHOPAEDIC MALLET HEAD 1-1/2" (3.8 CM) DIAMETER WEIGHT 2 LBS (908G) OVERALL LENGTH 7-9/16 ORTHOPAEDIC MALLET HEAD 1-1/2" (3.8 CM) DIAMETER WEIGHT 2 LBS (908G) OVERALL LENGTH 7-9/16"(19.3CM)
Catalog Number
OS1519
Brand Name
V. Mueller
Version/Model Number
OS1519
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)
Yes
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
f8e57b9f-eac8-4dde-bd6a-0eb3ee7bfa5b
Public Version Date
October 11, 2018
Public Version Number
1
DI Record Publish Date
September 10, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |