FDA.reportPublic FDA data

Millennium

Primary DI
00190776373320
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
2-770012INS
Device description
Laryngeal Mirror with handle, 12mm, 7 1/2", insulated black
Published
2023-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAXMIRROR, MOUTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776373320PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776373320001907763733201907763733200190776373320

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04251436934155KOHLERKohler Medizintechnik GmbHEAX2026-03-12
00840161311511Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-02-19
00840161311535Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-02-19
00840161311375Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311382Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311399Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311405Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311412Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311429Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311436Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00840161311443Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-01-05
00810126506726Essentials By 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAX2025-12-16
008101265067713D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAX2025-12-16
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00190707193270PixSure Perfect™Ortho Organizers, Inc.EAX2025-10-23
00190707149055PixSure Perfect®Ortho Organizers, Inc.EAX2025-10-01
0081000052669720/20™PARKELL, INC.EAX2025-09-26
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