KAMRA inlay

Basic Information

• Brand Name: KAMRA inlay
• Primary DI: 00813359020052
• Version / Model: 76225-10
• Company Name: ACUFOCUS, INC.
• Labeler DUNS: 138585281
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2017-01-13
• Public Version: 3
• Public Version Date: 2023-01-12
• Public Version Status: Update
• Public Device Record Key: 42e6d9cd-1ccc-402c-86c9-a57dae89c9d2
• Distribution End Date: 2022-02-03

Device Description

Carton Assy, US, KAMRA Pod, Dispenser Carton Assembly

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: No

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
47959	Corneal inlay, aperture reducing	A sterile implantable device inserted into the natural cornea to treat presbyopia [age-related hyperopia (far sightedness)] based on aperture reduction. It is typically made of plastic material and is shaped as a thin annulus (disc) formed to fit the curvature of the cornea; it includes a central opening that restricts the optical aperture of the eye to increase depth of field. It is intended for long-term implantation and is surgically inserted in an intrastromal pocket or flap made by a keratome or an appropriate laser.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813359020052	GS1
Unit of Use	00813359020069	GS1