FDA.reportPublic FDA data

Millennium

Primary DI
00190776195670
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-E321522
Device description
Hemostatic Clip Applier Curved Medium Clip
Published
2021-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDOApplier, surgical, clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776195670PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776195670001907761956701907761956700190776195670

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery ligation clip applierA hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during an open-surgery procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like); implantable clips are not included. This is a reusable device after sterilization.

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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800042700065Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700904Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700911Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042700928Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701369Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701376Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701390Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042701406Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702878Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702885Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702892Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702908Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702915Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08800042702922Artisential Clip Applier Medium LargeLIVSMEDGDO2026-04-29
08809756910081Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
08809756910104Artisential Clip Applier LargeLIVSMEDGDO2026-04-21
10381780540595CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
10381780540601CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2026-04-15
G58690311220Novo SurgicalNOVO SURGICAL, INC.GDO2025-03-25
10381780544302CODMAN®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGDO2024-10-02
14026704738110WECKTELEFLEX INCORPORATEDGDO2024-07-17
14026704726384WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726391WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726407WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726414WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726421WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726438WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726445WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726452WECKTELEFLEX INCORPORATEDGDO2024-03-13
14026704726469WECKTELEFLEX INCORPORATEDGDO2024-03-13