Primary Device ID | 00862394000260 |
NIH Device Record Key | 7a2830ac-8b3c-4acd-81ac-29ae6675801f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Boston Keratoprosthesis Snap-on Type I |
Version Model Number | TSR-100 |
Catalog Number | TSR-100 |
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 |
Phone | 617 573 4463 |
larisa_gelfand@meei.harvard.edu |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00862394000260 [Primary] |
HQM | Keratoprosthesis, Permanent Implant |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2015-10-30 |
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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. |