FDA.reportPublic FDA data

Maskin MG Probe 1mm

Primary DI
08600088329110
Brand
Maskin MG Probe 1mm
Company
MGD INNOVATIONS, LLC
Model
11-101
Device 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.
Published
2026-05-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMXCannula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMXCannula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18600088329117PackageGS15In Commercial Distribution
08600088329110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1860008832911718600088329117
08600088329110086000883291108600088329110

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, single-useA 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.

Contacts#

Phone, Email table
PhoneEmail
(813) 518-5338info@mgdi.com

Regulatory Flags#

DUNS number
876988572
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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