Duns Number:832696038
Device Description: V. Mueller ORAL BONE FILE CROSS-SERRATED OVERALL LENGTH 7" (17.8CM)
Catalog Number
MO10053
Brand Name
V. Mueller
Version/Model Number
MO10053
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 12, 2021
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
EMI
Product Code Name
FILE, BONE, SURGICAL
Public Device Record Key
4b96c7f3-f040-4466-be29-f3f205482f6d
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
August 30, 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 |