Duns Number:312623008
Device Description: The product MapperFrame supports the Automatic Registration process for image guided surge The product MapperFrame supports the Automatic Registration process for image guided surgery procedures with the Fiagon Navigation System.The MapperFrame is a reusable device. It can be used with a surgical sterile drape in the operating area. The MapperFrame is improper for treatment by autoclave or other sterilization procedures. The MapperFrame is intended to be used in connection with the iPad Remote Control.
Catalog Number
-
Brand Name
MapperFrame
Version/Model Number
1
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
8b9456c2-328e-46b0-8c3d-8914c23b82dd
Public Version Date
October 25, 2022
Public Version Number
4
DI Record Publish Date
November 21, 2017
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 | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 18 |