Inlay Inserter Chuck Handle

Basic Information

• Brand Name: Inlay Inserter Chuck Handle
• Primary DI: 10850394006051
• Version / Model: 607-0002
• Catalog Number: 607-0002
• Company Name: REVISION OPTICS, INC.
• Labeler DUNS: 015504442
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-19
• Public Version: 4
• Public Version Date: 2018-08-09
• Public Version Status: Update
• Public Device Record Key: 4bcb5c74-d5ed-4708-961d-df887e9282ba

Device Description

The Inlay Inserter Chuck Handle is used in conjunction with the Inlay Inserter to extend the length of the device for ease of use while delivering the Raindrop® Near Vision Inlay. The Inserter Handle has three components: the handle, the sleeve, and the chuck.

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LQE	Implant, Corneal, Refractive	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46724	Ophthalmic surgical instrument handle, manual	A hand-held manual device designed to hold and operate a compatible ophthalmic surgical instrument tip (typically scissors, forceps). It is typically in the form of a conventional handle with a connector that secures the inserted tip, and has a manually-operated internal actuating piston that operates the inserted tip (e.g., opens and closes blades). It is typically used for surgery in the anterior or the posterior segment to cut, grasp, and manipulate eye tissue; it is not a handle for a corneal trephine. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10850394006051	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P150034	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: In between use, store the packaged instrument in a dry and clean environment.