Model: BC4FB
Catalog: BC4FB
DI: B945BC4FB0
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
Empty Black Flipper with 4 Cells
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
cca4e0c1-f4c9-4d66-b42c-4cc7cd3eeb40
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:
B945BC4FB0
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 64350
Name: Vision testing/training flipper
Definition:
A device in the form of flipper lenses (two lenses on either side of a rotatable stem) intended to be used for the diagnosis and treatment of ophthalmic accommodation disorders. It consists of binocular spherical plus/minus lenses that can quickly be flipped from plus to minus, and which can be used by a healthcare professional for diagnosis or by a patient for self-training. This is a reusable device.
FDA Product Codes
HPB
Clip, Lens, Trial, Ophthalmic