FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776290665
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
3-3706
Device description
Orbital Retractor/Elevator
Published
2023-09-28
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
HNIRetractor, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNIRetractor, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776290665PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776290665001907762906651907762906650190776290665

GMDN Terms#

Term, Definition table
TermDefinition
Periocular/lacrimal retractor, self-retainingA self-retaining, ophthalmic surgical instrument intended to be used to draw aside the margins of a periocular surgical wound, typically to access the nasolacrimal duct/lacrimal sac during an ophthalmic intervention; it is not intended to retract tissues of the eyeball and is not an eyelid speculum. The instrument is typically designed with two conjoined legs and a self-retaining mechanism, and is usually made of stainless steel. 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
00190776434816Millennium1-GS1922902026-10-13
00190776434823Millennium72-5225509A12026-10-13
00190776434830Millennium72-2423052026-10-13
00190776434847Millennium72-2423102026-10-13
00190776434854Millennium72-5220358C32026-10-13
00190776434861Millennium72-244F2026-10-13
00190776434878Millennium72-31460012026-10-13
00190776434625Millennium92-323902026-10-12
00190776434632Millennium63-5046812026-10-12
00190776434649Millennium1-65677L2026-10-12
00190776434656Millennium100-S03481NSHR2026-10-12
00190776434663Millennium1-746105012026-10-12
00190776434670Millennium1-2420402026-10-12
00190776434687Millennium1-2027160042026-10-12
00190776434694Millennium1-IMDR2026-10-12
00190776434700Millennium1-13724INS2026-10-12
00190776434717Millennium72-12590212026-10-12
00190776434724Millennium72-321603SS2026-10-12
00190776434731Millennium72-321604SS2026-10-12
00190776434748Millennium1-8403002026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436520MilleniumAvalign Technologies, Inc.HNI2026-10-08
00724995318178V. MuellerSTERIS Deutschland GmbHHNI2026-09-25
B382SD1553000Surgical DirectSurgical Direct, Inc.HNI2026-07-31
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
00190776401276MillenniumAvalign Technologies, Inc.HNI2025-06-10