BUR 31312579 INDIGO RND STEEL CUT 2.5MM
Indigo™ - 31312579
Device Description
A small rotary shaft of hard metal (e.g., steel) or carbide, with fluting or cutting planes of various shapes at the working end, designed for incising or removing cartilage and/or bone from the ear, nose, or throat during an ear/nose/throat (ENT) procedure. It is usually power-driven by a rotary handpiece or other powered device. It is typically used in mastoid surgery, frontal sinus surgery, or surgery of the facial nerves. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
- Outer Diameter: 2.5 Millimeter
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: ERL
Device Name: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
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: 874.4250
Third Party Flag: Y
Medical Specialty: EN
Code: HBE
Device Name: Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: NE
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: 882.4310
Third Party Flag: Y
Medical Specialty: NE
Device IdentifiersDevice Id: 00643169579248
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