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Boston Keratoprosthesis Snap-on Type I TSR-100

by Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. FDA registration: United States GUDID

Product code HQM

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00862394000260 UDI-DIDate30 Oct 2015ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

GUDID · synced 22 Oct 2026

Trade Name
Boston Keratoprosthesis Snap-on Type I
Generic Name
Cornea prosthesis
Model / Ref / Catalog
TSR-100
Description
Boston Keratoprosthesis Snap-on TypeI Titanium locking ring
Primary DI / UDI-DI
00862394000260
510(k) Number
FDA Product Code
HQM
GMDN Term
Cornea prosthesis
Device Class
Class II
Regulation Number
886.3400
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Cornea prosthesis

Cleared under the same submission (K915062)

Other devices from Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.

See all devices from Massachusetts Eye and Ear Infirmary & Physician Staff, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date
Other properties (6)
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No

Sources (1)

  • FDA UDI 7a2830ac-8b3c-4acd-81ac-29ae6675801f 36 fields · synced 22 Oct 2026