Model: BC1270325NI
Catalog: BC1270325NI
DI: B945BC1270325NI0
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-03
Current Version: 2026-05-11
Description
Accommodative Flipper - No Imprint (+3.25D/-3.25D)
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
746d8b84-e67b-4ae0-8945-7ec5a6457a38
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:
B945BC1270325NI0
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