Duns Number:341702266
Device Description: The Field generator mounting arm serves as a mounting for the Field generator. The screw a The Field generator mounting arm serves as a mounting for the Field generator. The screw at its central hinge locks the position of all three joints. The base of the arm is clamped to the standard rail mount of surgical operation tables.
Catalog Number
U3 011 01
Brand Name
Field generator mounting arm
Version/Model Number
1.0
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
PGW
Product Code Name
Ear, Nose, And Throat Stereotaxic Instrument
Public Device Record Key
fae29b78-673e-4256-bfa0-753f802519b1
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
January 04, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |