FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776318826
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
2-1685D1
Device description
McGee 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
00190776318826PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776318826001907763188261907763188260190776318826

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
00190776400255Millennium85-770394842026-07-17
00190776400279Millennium85-612145882026-07-17
00190776400286Millennium85-650123442026-07-17
00190776400293Millennium85-650124292026-07-17
00190776400309Millennium85-530182002026-07-17
00190776400316Millennium85-640256632026-07-17
00190776400323Millennium85-642056792026-07-17
00190776400330Millennium85-140309902026-07-17
00190776400347Millennium85-500031652026-07-17
00190776400354Millennium85-640048772026-07-17
00190776400361Millennium85-140193092026-07-17
00190776400378Millennium85-710076432026-07-17
00190776400385Millennium85-710041182026-07-17
00190776400392Millennium85-430112722026-07-17
00190776400408Millennium12-8015252026-07-17
00190776400415Millennium12-8015242026-07-17
00190776400422Millennium85-220009752026-07-17
00190776400439Millennium85-220009792026-07-17
00190776400446Millennium85-230835912026-07-17
00190776400453Millennium85-170101252026-07-17

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
00190776318840MILLENNIUMAvalign 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