KAMRA inlay

GUDID 00813359020007

Carton Assembly, ACI 7000

ACUFOCUS, INC.

Corneal inlay, aperture reducing

• Primary Device ID: 00813359020007
• NIH Device Record Key: c822d2ab-f91c-49d7-a654-e7006a803b42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KAMRA inlay
• Version Model Number: 76043
• Company DUNS: 138585281
• Company Name: ACUFOCUS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813359020007 [Primary]

FDA Product Code

• LQE: Implant, Corneal, Refractive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-04-29

On-Brand Devices [KAMRA inlay]

• 00813359020052: Carton Assy, US, KAMRA Pod, Dispenser Carton Assembly
• 00813359020045: Carton Assy, US, KAMRA Pod, Unit Carton Assembly
• 00813359020007: Carton Assembly, ACI 7000