Device
The Meibomian Gland (MG) Probe is a sterile, single-use, handheld ophthalmic instrument with an angled shaft coupled to a fine, smooth probe tip intended to mechanically access and...
Manufacturer
MGD INNOVATIONS, LLC
MGD INNOVATIONS, LLC
Model: 11-101
DI: 08600088329110
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-07
Current Version: 2026-05-15
Description
The Meibomian Gland (MG) Probe is a sterile, single-use, handheld ophthalmic instrument with an angled shaft coupled to a fine, smooth probe tip intended to mechanically access and dilate obstructed meibomian gland orifices. The product family consists of multiple length probes and larger diameter tip dilators in order to access and mechanically open orificial and deeper obstructed glands.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b923c1fd-8f97-40ca-a1e4-068744c572bb
Distribution Status:
In Commercial Distribution
DUNS Number:
876988572
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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
Item #1 - Pkg Type:
Shelf carton
Item #1 - Device ID:
18600088329117
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
5
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
08600088329110
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08600088329110
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 44359
Name: Ophthalmic surgical probe, single-use
Definition:
A slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a single-use device.
FDA Product Codes
HMX
Cannula, Ophthalmic