Duns Number:963856096
Device Description: MAYFIELD® Infinity Skull Clamp System Triad Rocker Arm
Catalog Number
419B1206
Brand Name
MAYFIELD®
Version/Model Number
S419B1206
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
K051440
Product Code
HBL
Product Code Name
HOLDER, HEAD, NEUROSURGICAL (SKULL CLAMP)
Public Device Record Key
45e8efff-acda-4e88-a18b-d6e2abc88cfc
Public Version Date
October 25, 2022
Public Version Number
5
DI Record Publish Date
September 29, 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 | 1079 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2066 |