Duns Number:832696038
Device Description: V. Mueller Neuro/Spine VERSA-TRAC BASIC RETRACTOR SET W/INSTRUMENT CASE (Y-0155)
Catalog Number
Z-0151
Brand Name
V. Mueller
Version/Model Number
Z-0151
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
GZT
Product Code Name
RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY
Public Device Record Key
84d5f190-da13-4591-b7f6-ab396b797efa
Public Version Date
March 09, 2022
Public Version Number
3
DI Record Publish Date
September 23, 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 |