FDA.reportPublic FDA data

Millennium

Primary DI
00190776300135
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-304103F
Device description
"Hirschman Anoscope with Fiber Optics, 78"" x 2 38"""
Published
2023-11-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRETRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776300135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776300135001907763001351907763001350190776300135

GMDN Terms#

Term, Definition table
TermDefinition
Optical anoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. 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
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
00840319759400Hayden MedicalHayden Medical, Inc.GAD2026-09-04
00840319759417Hayden MedicalHayden Medical, Inc.GAD2026-09-04
04058749046076NAFehling Instruments GmbH & Co. KGGAD2026-09-04
00190776428129MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428259MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428266MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428273MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428280MillenniumAvalign Technologies, Inc.GAD2026-08-27
00192896123663Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27
00192896123670Meyerding Finger RetractorSONTEC INSTRUMENTS, INC.GAD2026-08-27
00190776423902MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427443MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427450MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427467MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427474MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427481MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427498MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427504MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427511MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427528MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427535MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427658MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427702MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427719MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427726MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776427818MillenniumAvalign Technologies, Inc.GAD2026-08-26
00190776420291MillenniumAvalign Technologies, Inc.GAD2026-08-25
G453FCE2004SI0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-25
G453FCE2005SI0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-08-25