FDA.reportPublic FDA data

Millennium

Primary DI
00190776435875
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-P605-20
Device description
Bladder Sound
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGMProbe And Director, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGMProbe And Director, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776435875PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776435875001907764358751907764358750190776435875

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18772891096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776433017Millennium1-3201222026-10-01
00190776433024Millennium1-5255712026-10-01
00190776433031Millennium72-52832404M2026-10-01
00190776433048Millennium1-3201042026-10-01
00190776433055Millennium1-7752SD2026-10-01
00190776433062Millennium72-31940512026-10-01
00190776433079Millennium72-317910012026-10-01
00190776433086Millennium72-180526NR2026-10-01
00190776433093Millennium72-4220812026-10-01
00190776433109Millennium1-3202132026-10-01
00190776433116Millennium1-2051362026-10-01
00190776433123Millennium72-23011WS2026-10-01
00190776433130Millennium72-2411004CM2026-10-01
00190776433147Millennium72-2411003CM2026-10-01
00190776433154Millennium72-5242002H2026-10-01
00190776433161Millennium72-5242003H2026-10-01
00190776433178Millennium72-2414002026-10-01
00190776433185Millennium92-H0498R2026-10-01
00190776432911Millennium72-2430130452026-09-30
00190776432928Millennium72-5225522B42026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776427825MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427832MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427849MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427856MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427863MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427870MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427887MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427894MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427900MillenniumAvalign Technologies, Inc.FGM2026-08-26
00190776427917MillenniumAvalign Technologies, Inc.FGM2026-08-26
00192896122826Barr ProbeSONTEC INSTRUMENTS, INC.FGM2026-03-10
00190776416201MillenniumAvalign Technologies, Inc.FGM2026-02-12
00192896122543Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00192896122550Probe With EyeSONTEC INSTRUMENTS, INC.FGM2025-11-21
00190776411831MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411848MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411855MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411862MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411879MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411886MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411893MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776411909MillenniumAvalign Technologies, Inc.FGM2025-09-25
00190776406325MillenniumAvalign Technologies, Inc.FGM2025-07-21
G453332312160PEAK MEDICALPeak Medical Distribution Inc.FGM2025-06-17
00190776399993MillenniumAvalign Technologies, Inc.FGM2025-06-03
04049047024422GimmiGimmi GmbHFGM2025-05-06
G4533352001180PEAK MEDICALPeak Medical Distribution Inc.FGM2025-01-20
G586G91027310Novo SurgicalNOVO SURGICAL, INC.FGM2024-10-15
04049197272230RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20
04049197272247RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFGM2024-09-20