Duns Number:832696038
Device Description: V. Mueller Neuro/Spine CHROMA-LINE SPINAL RONGEUR SINGLE RING HANDLE 1.5MM, UP, RED SHAFT V. Mueller Neuro/Spine CHROMA-LINE SPINAL RONGEUR SINGLE RING HANDLE 1.5MM, UP, RED SHAFT LENGTH 7" (180MM)
Catalog Number
U-0701
Brand Name
V. Mueller
Version/Model Number
U-0701
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 15, 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
HAE
Product Code Name
RONGEUR, MANUAL
Public Device Record Key
eae02ddd-dce4-4df5-9c1d-82efc1236338
Public Version Date
March 09, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2016
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 |