FDA.reportPublic FDA data

Millennium

Primary DI
00190776401160
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-380225
Device description
"Billeau Loop, 6 1/2"", large"
Published
2025-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
JYQLoop, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYQLoop, WireEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776401160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776401160001907764011601907764011600190776401160

GMDN Terms#

Term, Definition table
TermDefinition
Ear snareA hand-held manual surgical instrument intended to be inserted through the outer ear canal or through a surgical incision in the ear to remove tissue, typically tumorous or damaged tissue, from the ear during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the tissue to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). 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
00190776391683CONDUIT ZERO-P VA4514021002026-07-10
00190776391690CONDUIT ZERO-P VA4514021102026-07-10
00190776391706CONDUIT ZERO-P VA4514021202026-07-10
00190776391713CONDUIT ZERO-P VA4514030502026-07-10
00190776391720CONDUIT ZERO-P VA4514030602026-07-11
00190776391737CONDUIT ZERO-P VA4514030702026-07-11
00190776391744CONDUIT ZERO-P VA4514030802026-07-11
00190776391751CONDUIT ZERO-P VA4514030902026-07-11
00190776391768CONDUIT ZERO-P VA4514031002026-07-11
00190776391775CONDUIT ZERO-P VA4514031102026-07-11
00190776391782CONDUIT ZERO-P VA4514031202026-07-11
00190776391799CONDUIT ZERO-P VA4515010502026-07-11
00190776391805CONDUIT ZERO-P VA4515010602026-07-11
00190776391812CONDUIT ZERO-P VA4515010702026-07-11
00190776391829CONDUIT ZERO-P VA4515010802026-07-11
00190776391836CONDUIT ZERO-P VA4515010902026-07-11
00190776391843CONDUIT ZERO-P VA4515011002026-07-11
00190776391850CONDUIT ZERO-P VA4515011102026-07-11
00190776391867CONDUIT ZERO-P VA4515011202026-07-11
00190776391874CONDUIT ZERO-P VA4515020502026-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275778Intrace USAPILOTIS TECH LLCJYQ2026-07-03
00757770409921Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770416196Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770423514Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770433087Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00194613033118MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613033125MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613033132MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613046132MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613089160MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613089313MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613106270MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613108007MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613112240MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00840343726430GEN2SURGIX MEDICAL LLCJYQ2025-06-16
00194613089320MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-03-21
00194613107994MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-03-21
10840306828116Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-02-12
10840306828192Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-01-20
10840306828239Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-01-20
G22313930920Medetz Surgical InstrumentsMedetz Surgical Instruments LLCJYQ2025-01-14
10840306828130Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2024-12-10
04049197309271RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197312486RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321419RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321457RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321464RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197474399RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197477796RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
00887482112892Symmetry Guilford-WrightASPEN SURGICAL PRODUCTS, INC.JYQ2024-08-12