Device
Macula Integrity Tester Version II - Unit only with Blue Filter Slide
Manufacturer
Bernell
Bernell
Model: MIT2U
Catalog: MIT2U
DI: B945MIT2U0
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
Macula Integrity Tester Version II - Unit only with Blue Filter Slide
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d6900a43-4fd4-4d32-9ad5-4656e44f556b
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:
B945MIT2U0
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 32688
Name: Haidinger brush imager
Definition:
A mains electricity (AC-powered) ophthalmic device designed to produce an image consisting of two conical brush-like images with apexes touching (known as Haidinger brushes). The observation of the image characteristics by a patient through a Nicole prism facilitates his/her visual function evaluation, particularly the macular integrity.
FDA Product Codes
HIY
Brush, Haidinger, (Including Macular Integrity)