Model: MTBIFL
Catalog: MTBIFL
DI: B945MTBIFL0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-02
Current Version: 2026-05-11
Description
TBI with Flex Extenders
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
784bb1fe-0702-4414-8015-cc2f234fae83
Distribution Status:
In Commercial Distribution
DUNS Number:
175947340
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
B945MTBIFL0
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 16800
Name: Vision testing/training chart
Definition:
An ophthalmic chart or card printed with various symbols (e.g., letters, pictures or dots) intended to be used for testing visual acuity (e.g., Snellen chart) or testing and/or training accommodation and/or convergence or other amenable ophthalmic functions. The chart/card may be held in front of the patient or placed on a table or wall and may have specific user instructions depending on specific use. This is a reusable device.
FDA Product Codes
HJN
Transilluminator, Battery-Powered