FDA.reportPublic FDA data

Millennium

Primary DI
00190776415709
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-460102013
Device description
"Mirror 16mm Round Handle 13"" Overall Straight"
Published
2026-02-04
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
KAIMirror, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAIMirror, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776415709PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776415709001907764157091907764157090190776415709

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal mirror, reusableA hand-held manual surgical instrument with a mirror or a surface sufficiently polished to reflect enough undiffused light to form a virtual image of an object placed before it at the distal end, intended to be used for a laryngeal examination. The mirror is affixed at an angle to a long, slender shaft with a handle at the proximal end that is held by the doctor who can manipulate the mirror close to the site of interest in the throat. 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
00190776397050Millennium85-160P208832026-07-16
00190776397067Millennium85-530366172026-07-16
00190776397074Millennium85-720391422026-07-16
00190776397081Millennium14-50052026-07-16
00190776397104Millennium85-770498932026-07-16
00190776397111Millennium85-230675902026-07-16
00190776397128Millennium85-640041212026-07-16
00190776397135Millennium85-710186192026-07-16
00190776397142Millennium85-300243682026-07-16
00190776397159Millennium85-780096162026-07-16
00190776397166Millennium85-900102152026-07-16
00190776397173Millennium85-520023162026-07-16
00190776397180Millennium85-528137762026-07-16
00190776397197Millennium85-520111272026-07-16
00190776397463Millennium85-140308682026-07-16
00190776398484Millennium85-800001202026-07-16
00190776398651Millennium85-590P015832026-07-16
00190776398668Millennium85-710378692026-07-16
00190776398682Millennium85-710369342026-07-16
00190776398699Millennium85-710374012026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275839Intrace USAPILOTIS TECH LLCKAI2026-07-03
00757770426027Bausch + LombBausch & Lomb IncorporatedKAI2026-04-30
00757770457601Bausch + LombBausch & Lomb IncorporatedKAI2026-04-30
00190776420017MillenniumAvalign Technologies, Inc.KAI2026-04-15
00190776419165MillenniumAvalign Technologies, Inc.KAI2026-04-13
00190776417642MillenniumAvalign Technologies, Inc.KAI2026-03-04
09348811109620INKAThe Trustee for KAISER FAMILY TRUSTKAI2025-11-25
00190776413286MillenniumAvalign Technologies, Inc.KAI2025-10-09
04250676710079Atticus mirrorSpiggle & Theis Medizintechnik GmbHKAI2025-09-25
04250676718006Mirror, round, polishedSpiggle & Theis Medizintechnik GmbHKAI2025-09-19
00194613011741MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011758MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011772MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011789MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011802MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011826MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613011833MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613043865MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613044589MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049416MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049423MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049430MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049454MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049485MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049492MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613049515MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00194613103385MSI Precision Specialty InstrumentsMed Saver, Inc.KAI2025-08-01
00757770402847Bausch + LombBausch & Lomb IncorporatedKAI2025-07-28
00757770405664Bausch + LombBausch & Lomb IncorporatedKAI2025-07-28
00757770409273Bausch + LombBausch & Lomb IncorporatedKAI2025-07-28