SC1 HANDPIECE ED100 ROHS

SC1 HANDPIECE ED100 ROHS
MIDAS REX® - ED100

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

Handling Environment Temperature - Degrees Celsius

33.00
10.00

Storage Environment Temperature - Degrees Celsius

70.00
-40.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

Ethylene Oxide

Moist Heat or Steam Sterilization

Ethylene Oxide
Moist Heat or Steam Sterilization

Product Codes

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 Identifiers

Device Id: 00643169882720

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