FDA.report

Millennium

Primary DI
00190776205447
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
72-9850
Device description
LED Headlight System w Headband and Battery
Published
2021-11-02
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

Related Records

Contact Domains

Product Codes

CodeName
KYTLIGHT, EXAMINATION, MEDICAL, BATTERY POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776205447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776205447001907762054471907762054470190776205447

GMDN Terms

TermDefinition
Head-worn lampAn electrically-powered lamp mounted on a headband, helmet frame, or spectacles and intended to provide light directly onto the field of vision during a dental or surgical procedure. The light typically consists of a magnifying lens, a reflector, a light bulb, and a connection to its integral batteries or battery pack; it is not a fibreoptic light.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
04053755202690DELTA 30 UVHeine Optotechnik GmbH & Co. KGKYT2026-03-02
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B366LED0204PORTALEDEclerisKYT2026-01-23
04053755203314DELTA XHeine Optotechnik GmbH & Co. KGKYT2025-12-03
04053755203321DELTA X CPPHeine Optotechnik GmbH & Co. KGKYT2025-12-03
04053755203338DELTA X CPGHeine Optotechnik GmbH & Co. KGKYT2025-12-03
00851289007347FireflyFirefly GlobalKYT2025-07-18
04053755202928DELTAoneHeine Optotechnik GmbH & Co. KGKYT2025-04-30
07465850912003Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912010Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912027Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912034Dr. VampaDr Vampa S.R.L.KYT2025-03-10
07465850912041Dr. VampaDr Vampa S.R.L.KYT2025-03-10
00814005023526RADBL25Quality Aspirators, Inc.KYT2025-02-27
00814005023533RADBLC1Quality Aspirators, Inc.KYT2025-02-27
00814005023540RADFILM5Quality Aspirators, Inc.KYT2025-02-27
00814005023571RADHU2Quality Aspirators, Inc.KYT2025-02-27
00814005023595RADHUM4Quality Aspirators, Inc.KYT2025-02-27
00814005023618RADINST1Quality Aspirators, Inc.KYT2025-02-27
00814005024172RADC25Quality Aspirators, Inc.KYT2025-02-27
00814005024189RADFILM6Quality Aspirators, Inc.KYT2025-02-27
008140050242572 Pin Detachable CableQuality Aspirators, Inc.KYT2025-02-27
00814005024288M-CZQuality Aspirators, Inc.KYT2025-02-27
00814005024295M-ORTTL AssemblyQuality Aspirators, Inc.KYT2025-02-27
00814005024301M-COQuality Aspirators, Inc.KYT2025-02-27
00814005024370M-KEQuality Aspirators, Inc.KYT2025-02-27
00814005024387M-HBQuality Aspirators, Inc.KYT2025-02-27
00814005024394M-ORQuality Aspirators, Inc.KYT2025-02-27
00814005024400M-QFQuality Aspirators, Inc.KYT2025-02-27
00814005024431M-SUQuality Aspirators, Inc.KYT2025-02-27