AccessGUDID - DEVICE: Boston Keratoprosthesis Snap-on TypeI (00862394000208)

GUDID

Device Identifier (DI) Information

Brand Name: Boston Keratoprosthesis Snap-on TypeI
Version or Model: SOF-TI5A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SOF-TI5A
Company Name: Massachusetts Eye and Ear Infirmary & Physician Staff, Inc.

Primary DI Number: 00862394000208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073825945 *Terms of Use

Device Description: The Boston Keratoprosthesis Snap-on TypeI Aphakia

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HQM	Keratoprosthesis, Permanent Implant

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K915062	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5 Millimeter

Device Record Status

Public Device Record Key: 5cc2df0f-5fba-4e8a-b45d-c18930466e95
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 29, 2015