DEVICE: Phasor Drill (M710PH3202100)
Device Identifier (DI) Information
Phasor Drill
008-1011
Not in Commercial Distribution
PH-320-210
BIOTEX, INC.
008-1011
Not in Commercial Distribution
PH-320-210
BIOTEX, INC.
2 Flute Drill Bit.
Device Characteristics
| MR Unsafe | |
| 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? |
|---|---|---|---|---|
| 46275 | Craniotomy power tool system, battery-powered, single-use |
A dedicated battery-powered assembly of devices intended to be used to remove circular sections of the skull vault (calvarium) to provide access to the interior for diagnosis (e.g., the insertion of a neuroscope), or treatments [e.g., to alleviate intracranial pressure (ICP)]; it may also be used for the removal of a bone flap for brain surgery. It typically consists of a handpiece containing a motor (engine), a battery-pack, an attachment with a clutch system that disengages the cutting tool when the inner table has been penetrated preventing injury to the brain, and an exchangeable rotating cutting tool (e.g., a cranial drill bit, bur, trephine or perforator). This is a single-use device.
|
Obsolete | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
| KIJ | Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment |
| GFG | Bit, Surgical |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature: between -20 and 40 Degrees Celsius |
| Handling Environment Humidity: between 25 and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature: between 10 and 35 Degrees Celsius |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Device Size Text, specify: 210 mm usable length |
| Outer Diameter: 3.2 Millimeter |
Device Record Status
e5ae07db-7595-4cab-9a0e-81e5175b71a6
January 04, 2021
5
December 07, 2018
January 04, 2021
5
December 07, 2018
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