Model: 1658
DI: 00385640072410
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-13
Current Version: 2026-05-21
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b8c08d43-7cd4-4330-81b7-c21fbac584b6
Distribution Status:
In Commercial Distribution
DUNS Number:
965484699
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00385640072410
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 36237
Name: Lacrimal punctum plug
Definition:
A sterile device inserted into a punctal opening to prevent tear outflow in dry eye patients. This is a single-use device.
FDA Product Codes
LZU
Plug, Punctum
Premarket Submissions
Submission Number:
K030300
Supplement Number:
000