Phasor Drill PH-240-210

GUDID M710PH2402100

2 Flute Drill Bit.

BIOTEX, INC.

Craniotomy power tool system, battery-powered, single-use

• Primary Device ID: M710PH2402100
• NIH Device Record Key: b9cdbefd-0651-4e32-a20e-68475a98f943
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Phasor Drill
• Version Model Number: 008-1049
• Catalog Number: PH-240-210
• Company DUNS: 969792050
• Company Name: BIOTEX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0
• Outer Diameter: 2.4 Millimeter
• Device Size Text, specify: 0

Operating and Storage Conditions

• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 25 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M710PH2402100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161704

FDA Product Code

• HBE: Drills, Burrs, Trephines & Accessories (Simple, Powered)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-16
• Device Publish Date: 2019-12-06

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• M710PH2402100: 2 Flute Drill Bit.
• M710PH580700: 2 Flute Drill Bit.
• M710PH530700: 2 Flute Drill Bit.
• M710PH450700: 2 Flute Drill Bit.
• M710PH3202100: 2 Flute Drill Bit.
• M710008102804: 1