FDA.reportPublic FDA data

Avalign

Primary DI
00190776041762
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM59-2391
Device description
"Hirschman Anoscope Small OL 150mm(5 7/8"")"
Published
2023-11-13
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
HDFSPECULUM, VAGINAL, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776041762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776041762001907760417621907760417620190776041762

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
00190776411084Millennium85-780816802026-08-07
00190776411091Millennium85-590091642026-08-07
00190776411107Millennium85-428459942026-08-07
00190776411473Millennium85-420410542026-08-07
00190776411480Millennium85-720471982026-08-07
00190776411497Millennium85-510046232026-08-07
00190776411503Millennium85-320020492026-08-07
00190776411510Millennium85-520016892026-08-07
00190776411527Millennium85-520062662026-08-07
00190776411534Millennium85-400463172026-08-07
00190776411541Millennium85-650098522026-08-07
00190776411558Millennium85-650123692026-08-07
00190776411565Millennium85-170121992026-08-07
00190776411572Millennium85-210785222026-08-07
00190776411589Millennium85-600016902026-08-07
00190776423544Millennium1-263T2026-08-07
00190776423551Millennium63-G122582026-08-07
00190776423568Millennium72-4535040E2026-08-07
00190776423575Millennium1-1201492026-08-07
00190776423582Millennium1-43098252026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408817MillenniumAvalign Technologies, Inc.HDF2026-08-03
00190776422639MillenniumAvalign Technologies, Inc.HDF2026-08-03
00198506093845ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-29
00198506093852ELMEDELMED INCORPORATEDHDF2026-07-29
00198506093142ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093265ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093272ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093418ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
B382SD915038100Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038110Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038120Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915039110Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471000Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471130Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471140Surgical DirectSurgical Direct, Inc.HDF2026-07-28
00190776421939MillenniumAvalign Technologies, Inc.HDF2026-07-23
00198506091964ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-22
00198506091995ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-22
00198506092008ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-22
00198506091803ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-10
00198506091827ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-10
00198506091834ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-10
00850083275365Intrace USAPILOTIS TECH LLCHDF2026-07-03
00190776421632MillenniumAvalign Technologies, Inc.HDF2026-06-23
00810158211360PRINCETONPrinceton Medical Group, Inc.HDF2026-06-23
05060212052339Cusco Specula Metal SmallDTR MEDICAL LIMITEDHDF2026-06-10
05060212052346Cusco Specula Metal MediumDTR MEDICAL LIMITEDHDF2026-06-10
05060212052360Cusco Specula Metal LargeDTR MEDICAL LIMITEDHDF2026-06-10
05060411982314Cusco Specula Metal Large LongDTR MEDICAL LIMITEDHDF2026-06-10
05060411982321Cusco Specula Metal Large Extra LongDTR MEDICAL LIMITEDHDF2026-06-10