FDA.reportPublic FDA data

Millennium

Primary DI
00190776355418
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
3-0398
Device description
Gill Corneal Knife,
Published
2023-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNNKnife, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776355418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776355418001907763554181907763554180190776355418

GMDN Terms#

Term, Definition table
TermDefinition
Eye spudA hand-held, manual, ophthalmic surgical instrument intended to be used to remove a foreign body/object embedded in or adhering to the surface of the eye globe. It is typically made of high-grade stainless steel, and designed with a fine handle at the proximal end and a thin concave blade with a rounded nose at the distal end. The ophthalmologist uses this tip to remove the foreign body/object. 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
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013297954Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNN2026-08-07
00190776408824MillenniumAvalign Technologies, Inc.HNN2026-08-03
14546951616721MANI Ophthalmic KnifeMANI, INC.HNN2026-07-23
14546951627383MANI Ophthalmic KnifeMANI, INC.HNN2026-07-23
14546951627390MANI Ophthalmic KnifeMANI, INC.HNN2026-07-23
04251047902956Kelly Descemet Membrane PunchA1 Medical GmbHHNN2026-05-29
08052276033635Phaco Slit Knife 2.4 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033642Phaco Slit Knife 2.4 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033659Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033666Phaco Slit Knife 2.65 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033673Phaco Slit Knife 2.65 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033680Phaco Slit Knife 2.65 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033697Phaco Slit Knife 2.75 mm Bevel Up AngledAKTIVE SRLHNN2024-01-17
08052276033703Phaco Slit Knife 2.75 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033710Phaco Slit Knife 2.75 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033727Phaco Slit Knife 2.85 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033734Phaco Slit Knife 2.85 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033741Phaco Slit Knife 2.8 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033758Phaco Slit Knife 3.0 mm Bevel Up AngledAKTIVE SRLHNN2024-01-17
08052276033765Phaco Slit Knife 3.0 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033772Phaco Slit Knife 3.0 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033789Phaco Slit Knife 3.2 mm Bevel Up Angled AKTIVE SRLHNN2024-01-17
08052276033796Phaco Slit Knife 3.2 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033802Phaco Slit Knife 3.2 mm Dual Bevel Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033819Phaco Slit Knife 3.4 mm Bevel Up Angled with protectionAKTIVE SRLHNN2024-01-17
08052276033826Scleral Knife Angled AKTIVE SRLHNN2024-01-17
08052276033833Stab Knife 15° AKTIVE SRLHNN2024-01-17
08052276033840Stab Knife 15° with protectionAKTIVE SRLHNN2024-01-17
08052276033857Stab Knife 22,5°AKTIVE SRLHNN2024-01-17
08052276033864Stab Knife 22,5° with protectionAKTIVE SRLHNN2024-01-17