Boston Keratoprosthesis Click-on Type II CLF-TIIA

GUDID 00862394000291

The Boston Kertoprosthesis Click-on Type II Aphakia

Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.

Cornea prosthesis

• Primary Device ID: 00862394000291
• NIH Device Record Key: f09025bd-2946-42eb-95cb-832dd7d00eb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boston Keratoprosthesis Click-on Type II
• Version Model Number: CLF-TIIA
• Catalog Number: CLF-TIIA
• Company DUNS: 073825945
• Company Name: Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: 617 573 4463
• Email: larisa_gelfand@meei.harvard.edu

Device Dimensions

• Outer Diameter: 4.5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862394000291 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121203

FDA Product Code

• HQM: Keratoprosthesis, Permanent Implant

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-30

Devices Manufactured by Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.

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• 00086239500214 - Boston Keratoprosthesis Lucia type I with anodized back plate: 2021-08-23 Boston Keratoprosthesis Type I Lucia with anodized back plate 7.8 mm Brown ( BR); Blue ( BL).
• 00862394000208 - Boston Keratoprosthesis Snap-on TypeI: 2018-07-06 The Boston Keratoprosthesis Snap-on TypeI Aphakia
• 00862394000215 - Boston Keratoprosthesis Snap-on TypeI: 2018-07-06 The Boston Keratoprosthesis ( KPro) Snap-on TypeI, PMMA Aphakia
• 00862394000222 - Boston Keratoprosthesis Snap-on TypeI: 2018-07-06 Boston Keratoprosthesis, Snap-on TypeI. 8.5 mm PMMA Back Plate.
• 00862394000239 - Boston Keratoprosthesis Snap-on TypeI: 2018-07-06 Boston Keratoprosthesis Snap-on TypeI 7mm PMMA Back Plate
• 00862394000246 - Boston Keratoprosthesis Snap-on TypeI: 2018-07-06 Boston Keratoprosthesis Snap-on TypeI 8.5 mm Titanium Back Plate.
• 00862394000253 - Boston Keratoprosthesis Snap-on TypeI: 2018-07-06 Boston Keratoprosthesis Snap-on TypeI 7.0 mm Titanium Back Plate.