MICRODEBRIDER HANDPIECE

MICRODEBRIDER HANDPIECE
PELLO - 6290100000

Device Description

A handle with attached cutting blade that is a component of a line-powered ENT shaver system and designed to resect/debride soft and osseous (bone) tissue in the nasal cavity or ear region during ear/nose/throat (ENT) or plastic surgery procedures; including functional endoscopic sinus surgery (FESS). It is typically connected to and regulated through a dedicated control unit. It may facilitate additional functions of the system (e.g., irrigation/suction) and may be used in combination with appropriate endoscopic devices. This is a reusable device.

Environmental Conditions

Handling Environment Atmospheric Pressure - KiloPascal

106.00
70.00

Handling Environment Humidity - Percent (%) Relative Humidity

85.00
10.00

Handling Environment Temperature - Degrees Celsius

27.00
10.00

Storage Environment Atmospheric Pressure - KiloPascal

106.00
50.00

Storage Environment Humidity - Percent (%) Relative Humidity

90.00
10.00

Storage Environment Temperature - Degrees Celsius

50.00
-20.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

Moist Heat or Steam Sterilization

Moist Heat or Steam Sterilization

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

Device Identifiers

Device Id: 07613327524116

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