FDA.reportPublic FDA data

Millennium

Primary DI
00190776420840
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
92-H0419
Device description
"Conway Lid Retractor Width 8.4mm OL135mm (5 3/8"")"
Published
2026-04-30
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
HNIRetractor, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776420840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776420840001907764208401907764208400190776420840

GMDN Terms#

Term, Definition table
TermDefinition
Periocular/lacrimal retractor, hand-held, reusableA hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. 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
00190776403799MillenniumAvalign Technologies, Inc.HNI2026-07-21
00190776403805MillenniumAvalign Technologies, Inc.HNI2026-07-21
00190776420765MillenniumAvalign Technologies, Inc.HNI2026-04-30
00190776420512MillenniumAvalign Technologies, Inc.HNI2026-04-16
G22351091I0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNI2026-04-09
00190776418007MillenniumAvalign Technologies, Inc.HNI2026-03-23
00757770668427Bausch + LombBausch & Lomb IncorporatedHNI2026-02-04
00757770708260Bausch + LombBausch & Lomb IncorporatedHNI2026-02-04
00757770652518Bausch + LombBausch & Lomb IncorporatedHNI2025-09-12
00757770668083Bausch + LombBausch & Lomb IncorporatedHNI2025-09-12
G2231109830Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNI2025-08-11
00757770421985Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770423934Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770455720Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770510405Bausch + LombBausch & Lomb IncorporatedHNI2025-08-07
00757770437429Bausch + LombBausch & Lomb IncorporatedHNI2025-08-05
00757770668519Bausch + LombBausch & Lomb IncorporatedHNI2025-08-05
00194613005924MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613005948MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613085896MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
00194613104177MSI Precision Specialty InstrumentsMed Saver, Inc.HNI2025-08-01
04058935011826Berke-Jaeger Lid PlateBausch & Lomb GmbHHNI2025-07-11
00850003089355N/AOptalmed, LLCHNI2025-07-07
00850003089362N/AOptalmed, LLCHNI2025-07-07
G346EC1150Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNI2025-06-26
00190776401276MillenniumAvalign Technologies, Inc.HNI2025-06-10
G412H17300MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412H17350MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62010MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62020MR PHACOCrestpoint Management LimitedHNI2025-06-07