DEVICE: ClearFit VDI Standard (00860003416303)
Device Identifier (DI) Information
ClearFit VDI Standard
171716
In Commercial Distribution
LONGEVITI NEURO SOLUTIONS LLC
171716
In Commercial Distribution
LONGEVITI NEURO SOLUTIONS LLC
ClearFit VDI Standard
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
16131 | Cranial resinous compound |
A substance used to reconstitute cranial bone after neurosurgery (i.e., cranioplasty). It typically consists of a self-curing resin [e.g., polymethylmethacrylate (PMMA)] or a two part resinous material made of several compositions. It may be conformed as an inert implant in an appropriate shape (e.g., a plate) needed to repair the defect of the skull, either using an intraoperatively cured solid composition, or a preoperatively fabricated, porous, custom-made, implant. After application, this device cannot be reused.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GXN | Plate, Cranioplasty, Preformed, Non-Alterable |
PJN | Filler, Bone Void, Non-Alterable Compound For Cranioplasty |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K231920 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
85e18b07-0d82-4b2c-8e3e-bc74caf68722
February 27, 2025
1
February 19, 2025
February 27, 2025
1
February 19, 2025
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 |
---|---|
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
[?]
No Customer Contact currently defined