Model: TLRS+10.00
Catalog: TLRS+10.00
DI: B945TLRSP10000
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
Trial Lens Replacement Spherical +10.00
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
2a89df03-7f62-49fb-af44-0e48bf542499
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:
B945TLRSP10000
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 34653
Name: Vision corrective trial lens
Definition:
A non-patient-contact ophthalmic trial lens, or set of trial lenses of various dioptric powers, intended for vision testing to determine the required refraction for vision correction. This device may be used in conjunction with a phoropter (not included).
FDA Product Codes
HPC
Set, Lens, Trial, Ophthalmic