FDA.reportPublic FDA data

Millennium

Primary DI
00190776378523
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-4233830
Device description
Fiberoptic Sigmoidoscope Speculum Obturator 19mm x 30cm
Published
2023-09-08
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
KOASURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOASurgical Instruments, G-U, Manual (And Accessories)Gastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776378523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776378523001907763785231907763785230190776378523

GMDN Terms#

Term, Definition table
TermDefinition
Rigid sigmoidoscopeAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the sigmoid colon (the distal S-shaped part of the large intestine leading to the rectum). It is inserted through the anus during sigmoidoscopy or proctosigmoidoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used to examine the structures and lining of the sigmoid colon and for indications of altered bowel habit, colonic cancer, or polyps. 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
00190776407537Millennium85-900114502026-08-03
00190776407544Millennium85-220032892026-08-03
00190776407551Millennium85-200771242026-08-03
00190776407568Millennium85-440133392026-08-03
00190776408619Millennium9-8123302026-08-03
00190776408626Millennium85-500021432026-08-03
00190776408633Millennium85-528030162026-08-03
00190776408640Millennium85-668484472026-08-03
00190776408664Millennium85-650059602026-08-03
00190776408671Millennium85-220140482026-08-03
00190776408688Millennium85-780029742026-08-03
00190776408695Millennium85-600048132026-08-03
00190776408718Millennium85-250056502026-08-03
00190776408725Millennium85-600098002026-08-03
00190776408732Millennium85-160225992026-08-03
00190776408749Millennium85-710033452026-08-03
00190776408756Millennium85-620453222026-08-03
00190776408763Millennium85-120145262026-08-03
00190776408817Millennium85-310P447392026-08-03
00190776408824Millennium85-710026302026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD500500Surgical DirectSurgical Direct, Inc.KOA2026-08-03
00198506093630ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-29
00198506092169ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-27
00198506091933ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-22
00198506093128ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-22
00198506093135ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-22
00198506091759ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091810ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091841ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091858ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091889ELMED INCORPORATEDELMED INCORPORATEDKOA2026-07-10
00198506091483ELMED INCORPORATEDELMED INCORPORATEDKOA2026-06-09
00850081334040Zenflow Spring® Implant Retrieval DeviceZENFLOW, INC.KOA2026-05-22
00198506090882ELMED INCORPORATEDELMED INCORPORATEDKOA2026-05-15
00190776419288MillenniumAvalign Technologies, Inc.KOA2026-04-14
14026704941619PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
24026704941616PILLINGTELEFLEX INCORPORATEDKOA2026-03-23
00198506089640ELMED INCORPORATEDELMED INCORPORATEDKOA2026-03-17
10198956293243CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00198506088537ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
00198506088599ELMED INCORPORATEDELMED INCORPORATEDKOA2026-02-23
50198956293241CARDINAL HEALTHCardinal Health 200, LLCKOA2026-02-23
00190776417307MillenniumAvalign Technologies, Inc.KOA2026-02-20
00198506088155ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-22
00198506087363ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00198506087424ELMED INCORPORATEDELMED INCORPORATEDKOA2026-01-07
00190776414351MillenniumAvalign Technologies, Inc.KOA2025-10-23
00198506086151ELMED INCORPORATEDELMED INCORPORATEDKOA2025-10-20
00190776413569MillenniumAvalign Technologies, Inc.KOA2025-10-10
00190776412982MillenniumAvalign Technologies, Inc.KOA2025-10-07