FDA.reportPublic FDA data

Millennium

Primary DI
00190776434137
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-293212
Device description
Female Catheter 5 3/4" 12fr
Published
2026-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EZBStylet For Catheter, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZBStylet For Catheter, Gastro-UrologyGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776434137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776434137001907764341371907764341370190776434137

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
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
00190776437473Millennium1-290322402026-11-04
00190776437480Millennium1-290323402026-11-04
00190776437497Millennium1-FO455R2026-11-04
00190776437503Millennium1-CH20532026-11-04
00190776437510Millennium92-C02452026-11-04
00190776437527Millennium1-71015044T2026-11-04
00190776437534Millennium1-71015043T2026-11-04
00190776437541Millennium1-CTCS2026-11-04
00190776437558Millennium1-CTCL2026-11-04
00190776437565Millennium72-SM150621AC2026-11-04
00190776437572Millennium1-450399INS2026-11-04
00190776437589Millennium1-4103482026-11-04
00190776437596Millennium1-51061-62026-11-04
00190776437602Millennium72-5706082026-11-04
00190776437619Millennium1-470892026-11-04
00190776437626Millennium1-4601040132026-11-04
00190776437824Millennium1-7248382026-11-04
00190776437831Millennium72-1837962026-11-04
00190776437848Millennium72-1834242026-11-04
00190776437855Millennium1-713640262026-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435806MillenniumAvalign Technologies, Inc.EZB2026-10-21
00190776431150MillenniumAvalign Technologies, Inc.EZB2026-09-21
00190776421267MillenniumAvalign Technologies, Inc.EZB2026-05-04
00190776415419MillenniumAvalign Technologies, Inc.EZB2026-01-27
00190776389789MillenniumAvalign Technologies, Inc.EZB2024-11-18
00190776307356MillenniumAvalign Technologies, Inc.EZB2023-11-17
00190776303020MillenniumAvalign Technologies, Inc.EZB2023-11-16
00190776303341MillenniumAvalign Technologies, Inc.EZB2023-11-16
00190776302016MillenniumAvalign Technologies, Inc.EZB2023-11-15
00810143901191SURGIPROSSurgipros, LLCEZB2023-09-08
00190776350710MillenniumAvalign Technologies, Inc.EZB2023-01-10
00190776296933MillenniumAvalign Technologies, Inc.EZB2022-12-12
00190776163730MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163747MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163754MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163761MillenniumAvalign Technologies, Inc.EZB2021-11-01
00190776163778MillenniumAvalign Technologies, Inc.EZB2021-11-01
00827002448469Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00827002448483Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00827002448490Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00827002448551Motion Hybrid Wire GuideHERAEUS MEDICAL COMPONENTS LLCEZB2021-09-09
00801741051449NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051456NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051463NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051470NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051487NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051494NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051500NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051517NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23
00801741051524NiCore Nitinol GuidewireC. R. Bard, Inc.EZB2020-09-23