Boston Keratoprosthesis Click-on Type I CLF-IP

GUDID 00862394000284

The Boston Keratoprosthesis Click-on Type I Pseudophakia

Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.

Cornea prosthesis
Primary Device ID00862394000284
NIH Device Record Keya8b00560-53d3-4a89-bb0e-7a7598397c9c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoston Keratoprosthesis Click-on Type I
Version Model NumberCLF-IP
Catalog NumberCLF-IP
Company DUNS073825945
Company NameMassachusetts Eye and Ear Infirmary & Physician Staff, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone617 573 4463
Emaillarisa_gelfand@meei.harvard.edu

Device Dimensions

Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100862394000284 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQMKeratoprosthesis, Permanent Implant

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-30

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

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