FDA.reportPublic FDA data

Millennium

Primary DI
00190776189044
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-406830M
Device description
ProbeElevator FederOssoff Modified
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
CCWLARYNGOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776189044PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776189044001907761890441907761890440190776189044

GMDN Terms#

Term, Definition table
TermDefinition
Rigid laryngopharyngoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. 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
00198506089633ELMED INCORPORATEDELMED INCORPORATEDCCW2026-03-17
06974525071507Video LaryngoscopeShenzhen Zhixin Biomedical Technology Co., Ltd.CCW2026-02-04
00198506088063ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-22
00198506087868ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087875ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087882ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
00198506087905ELMED INCORPORATEDELMED INCORPORATEDCCW2026-01-15
05707480164264Ambu® SureSight® Data CableAmbu A/SCCW2025-12-19
05707480164301Ambu® SureSight® Battery ChargerAmbu A/SCCW2025-12-19
09348811110183INKAThe Trustee for KAISER FAMILY TRUSTCCW2025-11-25
10884521849761McGRATH MAC+Covidien LPCCW2025-11-17
00198506085727ELMED INCORPORATEDELMED INCORPORATEDCCW2025-09-19
04250676716095Surgical laryngoscopeSpiggle & Theis Medizintechnik GmbHCCW2025-09-19
04250381858431Laser laryngoscope, size 1, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858448Laser laryngoscope, size 2, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858455Laser laryngoscope, size 3, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858462Laser laryngoscope, size 4, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858479Laser laryngoscope, size 5, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858486Laser laryngoscope, size 6, black, forSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250381858493Laser laryngoscope, size 7, blackSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676739933Holinger laryngoscopeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676741646Laser laryngoscope, Ulm typeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
04250676741660Smoke evacuation tubeSpiggle & Theis Medizintechnik GmbHCCW2025-09-15
00840183530662BR Surgical, LLCBR Surgical, LLCCCW2025-08-21
20197344135667MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135834MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135919MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135933MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135964MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14
20197344135971MEDLINEMEDLINE INDUSTRIES, INC.CCW2025-08-14