FDA.reportPublic FDA data

Millennium

Primary DI
00190776400873
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
92-H0355
Device description
Wilder Lachrimal Dilator Size 1, 0.25mm fine tapered tip, round knurled handle, 100mm OL, stainless steel
Published
2025-06-05
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
HNWDilator, Lachrymal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNWDilator, LachrymalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776400873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776400873001907764008731907764008730190776400873

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal dilator, reusableA hand-held, manual, ophthalmic surgical instrument used for enlarging the lacrimal canal (the lacrimal duct) during an ophthalmic procedure. 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
00190776404093Millennium85-670332562026-07-24
00190776404109Millennium85-670332512026-07-24
00190776404116Millennium85-670332762026-07-24
00190776404123Millennium85-670332662026-07-24
00190776404130Millennium85-670332712026-07-24
00190776404147Millennium85-200831492026-07-24
00190776404178Millennium85-520033262026-07-24
00190776404185Millennium85-510002082026-07-24
00190776404192Millennium85-750802482026-07-24
00190776404208Millennium85-200801322026-07-24
00190776404215Millennium85-200801372026-07-24
00190776404222Millennium85-420472272026-07-24
00190776404239Millennium85-140181602026-07-24
00190776405748Millennium85-428302392026-07-24
00190776405755Millennium2-74002026-07-24
00190776405762Millennium85-780694882026-07-24
00190776405779Millennium85-530180862026-07-24
00190776405786Millennium85-770111652026-07-24
00190776405793Millennium85-780703032026-07-24
00190776405809Millennium85-250081402026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776421823MillenniumAvalign Technologies, Inc.HNW2026-06-24
04251047934155Gerten Dilator for the Easy Liquid Bubble DMEKA1 Medical GmbHHNW2026-06-09
00810158214538PRINCETONPrinceton Medical Group, Inc.HNW2026-04-21
00840319758892Hayden MedicalHayden Medical, Inc.HNW2026-03-31
00041533986560Bruder KarpeckiThe Hilsinger Company Parent, LlcHNW2025-11-21
00190776411619MillenniumAvalign Technologies, Inc.HNW2025-09-24
00194613010836MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010867MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613010874MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613051501MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
00194613083168MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-08-01
G412PH60850MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH6085T0MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60860MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60870MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60880MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60890MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60900MR PHACOCrestpoint Management LimitedHNW2025-05-27
G412PH60910MR PHACOCrestpoint Management LimitedHNW2025-05-27
00810158215191PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
00810158215207PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
00810158215214PRINCETONPrinceton Medical Group, Inc.HNW2025-05-27
G2231132500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNW2025-05-13
00810158215078PRINCETONPrinceton Medical Group, Inc.HNW2025-05-06
00194613010904MSI Precision Specialty InstrumentsMed Saver, Inc.HNW2025-03-21
00810158214514PRINCETONPrinceton Medical Group, Inc.HNW2025-03-13
00810158214521PRINCETONPrinceton Medical Group, Inc.HNW2025-03-13
00840183529758BR Surgical, LLCBR Surgical, LLCHNW2025-02-14
00810158214194PRINCETONPrinceton Medical Group, Inc.HNW2025-01-27
00757770410668Bausch + LombBausch & Lomb IncorporatedHNW2024-11-20