DEVICE: CRW® (10381780251347)
Device Identifier (DI) Information
CRW®
CRWPBSRAID
Not in Commercial Distribution
INTEGRA LIFESCIENCES CORPORATION
CRWPBSRAID
Not in Commercial Distribution
INTEGRA LIFESCIENCES CORPORATION
Special Arc Upgrade with target verification
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
35361 | Stereotactic radiosurgical invasive head frame |
A device intended to be affixed to a patient's skull to enable precise localization of an area within the brain targeted for radiosurgical procedures (e.g., radiation treatment of a brain tumour). It is typically an assembly that includes a head ring or a head frame that is attached to the patient's head with fixation screws partially-embedded into the skull, an arc mechanism for setting target coordinates, and localizer frames and adaptors for precision placement to the simulator and imaging system [e.g., computed tomography (CT), magnetic resonance imaging (MRI), linear accelerator]. This is a reusable device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HAW | Neurological stereotaxic Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K944463 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
fdca53e7-2dbd-4da5-83c9-168c6b50ca7f
March 19, 2024
4
July 26, 2016
March 19, 2024
4
July 26, 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 |
---|---|
HIBCC | M433CRWPBSRAID1 |
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(800)654-2873
custsvcnj@integralife.com
custsvcnj@integralife.com