Duns Number:832696038
Device Description: V. Mueller Neuro/Spine SHADOW-LINE MCCULLOCH NERVE ROOT RETRACTOR BLADE 6MM WIDE SHAFT LEN V. Mueller Neuro/Spine SHADOW-LINE MCCULLOCH NERVE ROOT RETRACTOR BLADE 6MM WIDE SHAFT LENGTH 6" (15.2CM)
Catalog Number
S-1991
Brand Name
V. Mueller
Version/Model Number
S-1991
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
HXB
Product Code Name
PROBE
Public Device Record Key
f2e13f9b-a01b-4124-aca8-271704171d1b
Public Version Date
March 10, 2022
Public Version Number
2
DI Record Publish Date
September 14, 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 |