Boston Keratoprosthesis Snap-on Type I TSR-100

GUDID 00862394000260

Boston Keratoprosthesis Snap-on TypeI Titanium locking ring

Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.

Cornea prosthesis
Primary Device ID00862394000260
NIH Device Record Key7a2830ac-8b3c-4acd-81ac-29ae6675801f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoston Keratoprosthesis Snap-on Type I
Version Model NumberTSR-100
Catalog NumberTSR-100
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 Identifiers

Device Issuing AgencyDevice ID
GS100862394000260 [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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