FDA.reportPublic FDA data

Millennium

Primary DI
00190776401276
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-0983
Device description
"Desmarres Lid Retractor, 5 1/2"" (14cm), 15mm, full matte finish"
Published
2025-06-10
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
00190776401276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776401276001907764012761907764012760190776401276

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA 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 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
00190776397029Millennium85-230835662026-07-22
00190776403874Millennium85-760P211392026-07-22
00190776403881Millennium85-900117122026-07-22
00190776403904Millennium85-710186242026-07-22
00190776403911Millennium85-220085422026-07-22
00190776403928Millennium85-100042872026-07-22
00190776403935Millennium85-100042862026-07-22
00190776403942Millennium85-140182802026-07-22
00190776403959Millennium85-600028502026-07-22
00190776403966Millennium85-600028542026-07-22
00190776403973Millennium85-530183682026-07-22
00190776403980Millennium85-120155172026-07-22
00190776404000Millennium85-670334872026-07-22
00190776404017Millennium9-553950032026-07-22
00190776404024Millennium85-670335682026-07-22
00190776404031Millennium9-553950012026-07-22
00190776404048Millennium85-670335142026-07-22
00190776404055Millennium85-670335882026-07-22
00190776404062Millennium85-670335732026-07-22
00190776404079Millennium85-670335962026-07-22

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
00190776420840MillenniumAvalign 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
G412H17300MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412H17350MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62010MR PHACOCrestpoint Management LimitedHNI2025-06-07
G412PH62020MR PHACOCrestpoint Management LimitedHNI2025-06-07