EG1™

Basic Information

• Brand Name: EG1™
• Primary DI: 00845384018759
• Version / Model: WIRELESS-HC
• Catalog Number: WIRELESS-HC
• Company Name: Anspach Effort, The
• Labeler DUNS: 079116867
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-08
• Public Version: 1
• Public Version Date: 2022-07-18
• Public Version Status: New
• Public Device Record Key: 1c094402-f5f4-45f3-a834-78cb43af2869

Device Description

Wireless Hand Control, EG1A

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ERL	DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE	Ear, Nose, Throat	874.4250	2
HBC	MOTOR, DRILL, ELECTRIC	Neurology	882.4360	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47864	Surgical power tool hand-switch	A handle-like device that is attached (clips or is slid onto the cylindrical barrel) to an electrically- or pneumatically-powered surgical power tool handpiece or motor of the micro types (a drill or a saw) so that the two devices interact to function as a switch used by the operating surgeon to hand activate (start and stop) the handpiece/motor. It is typically made of metal and/or synthetic materials and will typically include a sliding lock that, when brought into use by the surgeon, will lock the handle in the "On" position. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845384018759	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K220485	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 30 – 90 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry
• Type: Storage Environment Temperature
• Temperature Range: -20 – 140 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Do not use if package is damaged