Duns Number:312623008
Device Description: The product Localizer Bone Anchor is a product variant of a patient reference localisator The product Localizer Bone Anchor is a product variant of a patient reference localisator for image guidedsurgical procedures for cranial indications.
Catalog Number
-
Brand Name
Localizer Bone Anchor
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
K163209,K163209
Product Code
HAW
Product Code Name
Neurological Stereotaxic Instrument
Public Device Record Key
a1246085-7f59-408b-a6f2-62d47e275fd6
Public Version Date
October 25, 2022
Public Version Number
3
DI Record Publish Date
March 27, 2020
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 |