FDA.reportPublic FDA data

Millennium

Primary DI
00190776434236
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-659220
Device description
Mills Endarterectomy Loop, 0.4mm
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
DWSInstruments, Surgical, Cardiovascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776434236PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776434236001907764342361907764342360190776434236

GMDN Terms#

Term, Definition table
TermDefinition
Endarterectomy loopA hand-held manual surgical instrument intended to be used to grip and excise atherosclerotic deposits (i.e., thickened atheromatous tunica intima) from the lumen of an artery (i.e., endarterectomy). It will typically consist of a slender handle onto which a piece of flexible wire that ends in a small loop is attached or be used together with an endarterectomy loop puller. It is typically inserted percutaneously under radiographic guidance. It is made of high-grade stainless steel. 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
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
00190776434021Millennium72-232015LH2026-10-09
00190776434038Millennium72-401558LC2026-10-09
00190776434045Millennium72-402032PLC2026-10-09
00190776434052Millennium72-402190LC2026-10-09
00190776434069Millennium1-5103352026-10-09
00190776434076Millennium92-H04102026-10-09
00190776434083Millennium72-31960312026-10-09
00190776434090Millennium72-31960632026-10-09
00190776434106Millennium72-31960362026-10-09
00190776434113Millennium1-56152026-10-09
00190776434120Millennium1-37440302026-10-09
00190776434137Millennium1-2932122026-10-09
00190776434144Millennium1-455-162026-10-09
00190776434151Millennium1-710150432026-10-09
00190776434168Millennium1-4002882026-10-09
00190776434175Millennium72-3622089PC2026-10-09
00190776434182Millennium1-MDS13656022026-10-09
00190776434199Millennium72-586007C2026-10-09
00190776434205Millennium1-144011202026-10-09
00190776434212Millennium1-BT201R2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03661219320265DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219438601DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219442943DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219528388DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
00190776436216MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436254MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436315MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436353MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436377MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776436438MillenniumAvalign Technologies, Inc.DWS2026-10-08
00190776434410MillenniumAvalign Technologies, Inc.DWS2026-10-07
00190776434489MillenniumAvalign Technologies, Inc.DWS2026-10-07
00190776434298MillenniumAvalign Technologies, Inc.DWS2026-10-06
00190776434359MillenniumAvalign Technologies, Inc.DWS2026-10-06
00190776433307MillenniumAvalign Technologies, Inc.DWS2026-10-05
03661219323785DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
03661219323815DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
03661219323822DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
03661219323839DELACROIX-CHEVALIERLANDANGERDWS2026-09-30
00190776432843MillenniumAvalign Technologies, Inc.DWS2026-09-29
B040MIRSTS0Sterilization TrayGENESEE BIOMEDICAL, INC.DWS2026-09-29
03661219527688DELACROIX-CHEVALIERLANDANGERDWS2026-09-27
00724995286651V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286668V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286675V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
00724995286682V. MuellerSTERIS Deutschland GmbHDWS2026-09-25
10884389855416NAMICMEDLINE INDUSTRIES, INC.DWS2026-09-25
04058749012446NAFehling Instruments GmbH & Co. KGDWS2026-09-21
00192896123762TAVR Removal SetSONTEC INSTRUMENTS, INC.DWS2026-09-18
B040PHR10Premature Hinged Sternal RetractorGENESEE BIOMEDICAL, INC.DWS2026-09-18