FDA.reportPublic FDA data

Millennium

Primary DI
00190776299842
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-2046E
Device description
"Ebonized Mayo Needle Holder 7"""
Published
2023-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776299842PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776299842001907762998421907762998420190776299842

GMDN Terms#

Term, Definition table
TermDefinition
Epicardial pacing leadAn implantable flexible wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pacemaker to the heart. It may also transmit electrical responses from the heart back to the pacemaker; it is not intended to conduct defibrillation impulses. The electrode end is normally implanted in the outer surface of the heart (epicardium) in close contact to the wall of one of the chambers of the heart (endocardium), and the other end is connected to the pacemaker. It may be impregnated with a steroid (e.g., dexamethasone) intended to elute into the tissues to reduce inflammation.

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
G043201100BEARBear-Ent, LLCGEN2026-04-17
G043201130BEARBear-Ent, LLCGEN2026-04-17
G043201140BEARBear-Ent, LLCGEN2026-04-17
G043201160BEARBear-Ent, LLCGEN2026-04-17
G043201190BEARBear-Ent, LLCGEN2026-04-17
G043201200BEARBear-Ent, LLCGEN2026-04-17
09348811008756INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009029INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009050INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811009135INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811010155INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
09348811151162INKAThe Trustee for KAISER FAMILY TRUSTGEN2025-11-19
G586D75480250NovosurgicalNOVO SURGICAL, INC.GEN2024-12-30
KTS1017012K.T.SurgicoK.T.SURGICOGEN2024-02-20
KTS1018012K.T.SurgicoK.T.SURGICOGEN2024-02-20
KTS1222112K.T.SurgicoK.T.SURGICOGEN2024-02-20
GYNX32071GynexGYNEX CORPORATIONGEN2023-12-26
07898506812424QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812479QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812516QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812639QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812646QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812691QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812769QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812806QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506812813QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506813803QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506813810QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506850198QuinelatoSchobell Industrial LtdaGEN2023-01-10
07898506852772QuinelatoSchobell Industrial LtdaGEN2023-01-10