FDA.reportPublic FDA data

Millennium

Primary DI
00190776420482
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
92-CM010560
Device description
THORTON LOW-PROFILE PIN MARKER 6.00MM
Published
2026-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HMRMarker, Ocular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HMRMarker, OcularOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776420482PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776420482001907764204821907764204820190776420482

GMDN Terms#

Term, Definition table
TermDefinition
Corneal marker, reusableA manual instrument intended to be used to imprint, indent, and/or incise corneal tissue prior to an ophthalmic surgical procedure. It is typically made of high-grade stainless steel and includes a long slender handle with a distal end having characteristics for producing specific markings. The device may have a defined pattern of fine marking surfaces (e.g., cross hairs, symmetrical or asymmetrical interlinking wires) that simultaneously engage corneal tissue. Some types are used with a corneal marking pad to transfer ink to the anterior of the eye; other types are used with a slit lamp to precisely incise vertical and horizontal points for precision alignment. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776417116Millennium85-170103022026-08-19
00190776417123Millennium85-170103072026-08-19
00190776417130Millennium85-150210582026-08-19
00190776417147Millennium85-200817712026-08-19
00190776417154Millennium85-770057162026-08-19
00190776417161Millennium85-538056882026-08-19
00190776417178Millennium85-320071642026-08-19
00190776417192Millennium85-780866482026-08-19
00190776417208Millennium85-330848342026-08-19
00190776417215Millennium85-330848142026-08-19
00190776417222Millennium85-330848192026-08-19
00190776417239Millennium85-638014582026-08-19
00190776417246Millennium85-230826882026-08-19
00190776417253Millennium85-230811872026-08-19
00190776417710Millennium85-230811922026-08-19
00190776417727Millennium85-124162352026-08-19
00190776426569Millennium1-466322026-08-19
00190776426576Millennium92-F1750T2026-08-19
00190776426583Millennium1-911-52026-08-19
00190776426590Millennium1-910-52026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G223140410T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMR2026-07-27
03700483628179MORIAMORIA SAHMR2026-07-16
03700483628209MORIAMORIA SAHMR2026-07-16
03700483628261MORIAMORIA SAHMR2026-07-16
04251047934674Gerten Cornea Zone MarkerA1 Medical GmbHHMR2026-05-29
00757770714643Bausch + LombBausch & Lomb IncorporatedHMR2026-05-11
00757770520114Bausch + LombBausch & Lomb IncorporatedHMR2026-04-30
00840516145808Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00840516145815Anodyne SurgicalPsi/Eye-Ko, Inc.HMR2026-04-17
00190776420062MillenniumAvalign Technologies, Inc.HMR2026-04-15
00190776419387MillenniumAvalign Technologies, Inc.HMR2026-04-14
00190776418984MillenniumAvalign Technologies, Inc.HMR2026-04-13
00841668144299KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144305KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144312KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144329KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144336KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144343KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144350KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144367KatenaKATENA PRODUCTS, INC.HMR2026-03-31
00841668144374KatenaKATENA PRODUCTS, INC.HMR2026-03-31
G346BP01RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-03-02
G346ET160Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-02-17
00642356004709Mastel Surgical Inc.Mastel Surgical Inc.HMR2026-02-11
B382S34556140Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S4901000Surgical DirectSurgical Direct, Inc.HMR2026-02-04
B382S5616020Surgical DirectSurgical Direct, Inc.HMR2026-02-04
G346ET390Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHMR2026-01-21
B382S345201000Surgical DirectSurgical Direct, Inc.HMR2025-12-10
G22312270490Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHMR2025-11-05