FDA.reportPublic FDA data

Avalign

Primary DI
00190776049096
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM106-5435
Device description
Laryngeal Mirror
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
KAIMIRROR, ENT

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776049096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776049096001907760490961907760490960190776049096

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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00190776415709MillenniumAvalign Technologies, Inc.KAI2026-02-04
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