CONSOLE 1898001 IPC
NA - 1898001
Device Description
A pneumatically-powered (gas-powered) component of a surgical power tool system intended to regulate the gas pressure supplied to the pneumatic handpiece/motor (not included) and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.
Environmental Conditions
- 33.00
- 10.00
- 70.00
- -40.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
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
Device IdentifiersDevice Id: 00613994436412
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