FDA UDI
In Commercial Distribution
🇺🇸 United States
Boston Keratoprosthesis Click-on Type II
DI: 00862394000291
·
Model: CLF-TIIA
·
Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Boston Keratoprosthesis Click-on Type II
- Primary DI
- 00862394000291
- Version / Model
- CLF-TIIA
- Catalog Number
- CLF-TIIA
- Company Name
- Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.
- Labeler DUNS
- 073825945
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2015-10-30
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- f09025bd-2946-42eb-95cb-832dd7d00eb9
Device Description
The Boston Kertoprosthesis Click-on Type II Aphakia
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HQM | Keratoprosthesis, Permanent Implant | Ophthalmic | 886.3400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42525 | Cornea prosthesis | An implantable artificial substitute for a natural cornea used to improve/restore the vision of an adult patient with corneal opacity. Also known as a keratoprosthesis, this is usually a two-component device made of, e.g., poly 2-hydroxyethylmethacrylate (PHEMA), one component being a small fine threaded flange that is attached to the anterior of the eye and the other being the lens, which is a solid cylinder of this material, threaded at the distal end and convex at the proximal end. This lens is threaded into the flange proving the user with a window through which he or she can see. This device may be used when other interventions are not possible. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00862394000291 | GS1 |
Customer Contacts
- Phone
- 617 573 4463
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121203 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4.5 | Millimeter |