Duns Number:314546664
Device Description: BodyFIX® 14 Base Plate Stereotactic MRI is specially designed for using BodyFIX stereotact BodyFIX® 14 Base Plate Stereotactic MRI is specially designed for using BodyFIX stereotactic on non-indexed MRI couchtops.
Catalog Number
P10102-113
Brand Name
BodyFIX
Version/Model Number
P10102-113
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 16, 2020
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
IYE
Product Code Name
Accelerator, Linear, Medical
Public Device Record Key
a502363d-2be6-43a0-bf63-e0705a29f56a
Public Version Date
July 21, 2020
Public Version Number
3
DI Record Publish Date
August 23, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 175 |