DEVICE: Leksell Stereotactic System (07340048301039)
Device Identifier (DI) Information
Leksell Stereotactic System
1002031
In Commercial Distribution
Elekta Instrument AB
1002031
In Commercial Distribution
Elekta Instrument AB
CT TABLE FIXATION FOR PHILIPS NON-METAL
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
32568 | Neurological stereotactic surgery system |
An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HAW | Neurological stereotaxic Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
ee94d682-ad28-45c2-b7c8-c5015f616cc0
August 12, 2019
4
September 24, 2016
August 12, 2019
4
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)693-5358
info.america@elekta.com
info.america@elekta.com