FDA.reportPublic FDA data

Millennium

Primary DI
00190776370749
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-3140030A
Device description
Cystoscope, ACMI
Published
2023-04-03
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
NWWHysteroscope accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776370749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776370749001907763707491907763707490190776370749

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical hysteroscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the canal of the cervix and the uterine cavity (uterus). It is inserted through the vagina during hysteroscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. Distention of the uterus with, e.g., carbon dioxide(CO2) gas may be used to improve viewing. This device is commonly used to evaluate/treat fibroids (myomas), polyps, or causes of severe cramping (dysmenorrhea), heavy menstrual periods (menorrhagia), and bleeding between periods (metrorrhagia). 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
06974880994343Omni® Hysteroscopic GrasperSuzhou AcuVu medical technology Co., Ltd.NWW2026-04-17
00190776420208MillenniumAvalign Technologies, Inc.NWW2026-04-16
05708265017881LiNA OperaScope™ Lasso LiNA Medical AGNWW2026-04-03
05708265017904LiNA OperaScopeTM LassoLiNA Medical AGNWW2026-04-03
05708265017928LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017942LiNA OperaScope Angled LassoLiNA Medical AGNWW2026-04-03
05708265017980LiNA OperaScope™ ScissorsLiNA Medical AGNWW2026-04-03
00190776416379MillenniumAvalign Technologies, Inc.NWW2026-02-16
00850033976359HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
10850033976356HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
00198506087943ELMED INCORPORATEDELMED INCORPORATEDNWW2026-01-16
00190776410872MillenniumAvalign Technologies, Inc.NWW2025-09-15
00190776410544MillenniumAvalign Technologies, Inc.NWW2025-09-11
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06976860690511OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690528OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690535OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690542OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690559OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690566OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690573OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28