FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776318840
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
2-169823
Device description
Schuknecht Wire Crimper,
Published
2023-09-28
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
NNNCRIMPER, WIRE, ENT, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNNCrimper, Wire, Ent, Non-SterileEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776318840PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776318840001907763188401907763188400190776318840

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. 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
00190776397050Millennium85-160P208832026-07-16
00190776397067Millennium85-530366172026-07-16
00190776397074Millennium85-720391422026-07-16
00190776397081Millennium14-50052026-07-16
00190776397104Millennium85-770498932026-07-16
00190776397111Millennium85-230675902026-07-16
00190776397128Millennium85-640041212026-07-16
00190776397135Millennium85-710186192026-07-16
00190776397142Millennium85-300243682026-07-16
00190776397159Millennium85-780096162026-07-16
00190776397166Millennium85-900102152026-07-16
00190776397173Millennium85-520023162026-07-16
00190776397180Millennium85-528137762026-07-16
00190776397197Millennium85-520111272026-07-16
00190776397463Millennium85-140308682026-07-16
00190776398484Millennium85-800001202026-07-16
00190776398651Millennium85-590P015832026-07-16
00190776398668Millennium85-710378692026-07-16
00190776398682Millennium85-710369342026-07-16
00190776398699Millennium85-710374012026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613028862MSI Precision Specialty InstrumentsMed Saver, Inc.NNN2025-08-01
00840183527457BR Surgical, LLCBR Surgical, LLCNNN2024-11-26
00888515227378BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.NNN2024-02-28
00842331191398Novo SurgicalNOVO SURGICAL, INC.NNN2023-12-18
G586E7212440Novo SurgicalNOVO SURGICAL, INC.NNN2023-12-18
G586E7212450Novo SurgicalNOVO SURGICAL, INC.NNN2023-12-18
00190776318871MillenniumAvalign Technologies, Inc.NNN2023-11-13
00190776043605AvalignAvalign Technologies, Inc.NNN2023-09-28
00190776318826MILLENNIUMAvalign Technologies, Inc.NNN2023-09-28
14026704804228PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
14026704804235PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
14026704804273PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
54026704804233PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
54026704804226PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
54026704804271PILLINGTELEFLEX INCORPORATEDNNN2022-12-08
00842331174704Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-14
00842331177682Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-14
00842331186219Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-14
00842331146206Novo Surgical Inc. NOVO SURGICAL, INC.NNN2022-11-11
00887482112908Symmetry HouseASPEN SURGICAL PRODUCTS, INC.NNN2022-09-28
00887482113004Symmetry ScheerASPEN SURGICAL PRODUCTS, INC.NNN2022-09-28
00190776043575AvalignAvalign Technologies, Inc.NNN2021-11-03
00190776043582AvalignAvalign Technologies, Inc.NNN2021-11-03
00190776043612AvalignAvalign Technologies, Inc.NNN2021-11-03
00190776188658MillenniumAvalign Technologies, Inc.NNN2021-11-01
00190660056643Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660063733Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660063740Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660072605Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07
00190660072797Ambler SurgicalAMBLER SURGICAL CORP.NNN2021-01-07