4mm Angled 15 Degree Diamond Bur

4mm Angled 15 Degree Diamond Bur
PELLO - 629051214015

Device Description

A rotary cutting device made of a high-grade steel shank with the working end coated with particles of diamond, and which is designed to fit into a powered handpiece that provides the rotation for incising or removing bone in the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Handling Environment Humidity - Percent (%) Relative Humidity

75.00
30.00

Handling Environment Temperature - Degrees Celsius

27.00
10.00

Storage Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Storage Environment Humidity - Percent (%) Relative Humidity

75.00
10.00

Storage Environment Temperature - Degrees Celsius

40.00
-20.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: EQJ

Device Name: Bur, Ear, Nose And Throat

Device Class: 1

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: EN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 874.4140

Third Party Flag: N

Medical Specialty: EN

Device Identifiers

Device Id: 07613327579031

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A