FDA.reportPublic FDA data

Millennium

Primary DI
00190776189433
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
FTIMG10011
Device description
Fiberoptic Cable S ST
Published
2021-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EQHSOURCE, CARRIER, FIBEROPTIC LIGHT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQHSource, Carrier, Fiberoptic LightEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776189433PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776189433001907761894331907761894330190776189433

GMDN Terms#

Term, Definition table
TermDefinition
Operating room lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

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
00198506090868ELMED INCORPORATEDELMED INCORPORATEDEQH2026-05-18
00190776417680MillenniumAvalign Technologies, Inc.EQH2026-03-04
00198506088841ELMED INCORPORATEDELMED INCORPORATEDEQH2026-02-23
00190776415716MillenniumAvalign Technologies, Inc.EQH2026-02-04
00198506088056ELMED INCORPORATEDELMED INCORPORATEDEQH2026-01-22
00198506087059ELMED INCORPORATEDELMED INCORPORATEDEQH2025-12-03
00198506086786ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086854ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086908ELMED INCORPORATEDELMED INCORPORATEDEQH2025-11-25
00198506086250ELMED INCORPORATEDELMED INCORPORATEDEQH2025-10-20
00190776413347MillenniumAvalign Technologies, Inc.EQH2025-10-09
04250676736000Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736024Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736031Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
04250676736055Fiberglass light carrierSpiggle & Theis Medizintechnik GmbHEQH2025-09-15
00198506085079ELMED INCORPORATEDELMED INCORPORATEDEQH2025-09-05
00840183530679BR Surgical, LLCBR Surgical, LLCEQH2025-09-05
00190776408534MillenniumAvalign Technologies, Inc.EQH2025-08-19
00194613020132MSI Precision Specialty InstrumentsMed Saver, Inc.EQH2025-08-01
00194613123154MSI Precision Specialty InstrumentsMed Saver, Inc.EQH2025-08-01
00190776406769MillenniumAvalign Technologies, Inc.EQH2025-07-24
00190776406431MillenniumAvalign Technologies, Inc.EQH2025-07-21
00190776377137MillenniumAvalign Technologies, Inc.EQH2025-07-18
00190776406172MillenniumAvalign Technologies, Inc.EQH2025-07-18
00198506084089ELMED INCORPORATEDELMED INCORPORATEDEQH2025-07-17
00190776402815MillenniumAvalign Technologies, Inc.EQH2025-06-30
00198506083716ELMED INCORPORATEDELMED INCORPORATEDEQH2025-06-23
00190776401474MillenniumAvalign Technologies, Inc.EQH2025-06-10
00190776400019MillenniumAvalign Technologies, Inc.EQH2025-06-03
00198506083020ELMED INCORPORATEDELMED INCORPORATEDEQH2025-05-28