FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776310738
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
85-11010127
Device description
Wire Cutting Scissor,
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
NNUSCISSORS, WIRE CUTTING, ENT, NON-STERILE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776310738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776310738001907763107381907763107380190776310738

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
00190776391560CONDUIT ZERO-P VA4514010602026-07-09
00190776391577CONDUIT ZERO-P VA4514010702026-07-09
00190776391584CONDUIT ZERO-P VA4514010802026-07-09
00190776391591CONDUIT ZERO-P VA4514010902026-07-09
00190776391607CONDUIT ZERO-P VA4514011002026-07-09
00190776391614CONDUIT ZERO-P VA4514011102026-07-09
00190776391621CONDUIT ZERO-P VA4514011202026-07-09
00190776391638CONDUIT ZERO-P VA4514020502026-07-09
00190776391645CONDUIT ZERO-P VA4514020602026-07-09
00190776391652CONDUIT ZERO-P VA4514020702026-07-09
00190776391669CONDUIT ZERO-P VA4514020802026-07-09
00190776391676CONDUIT ZERO-P VA4514020902026-07-09
00190776391553CONDUIT ZERO-P VA4514010502026-07-08
00190776421847Millennium1-3KF-52026-06-25
00190776421694Millennium72-24655152026-06-24
00190776421700Millennium1-1701922026-06-24
00190776421717Millennium1-1701942026-06-24
00190776421724Millennium1-77ST42026-06-24
00190776421731Millennium72-5211303C2026-06-24
00190776421748Millennium1-343003H2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810123208654Adler Instrument CompanyAdler, Inc.NNU2025-03-04
00887482173930Symmetry BeebeeASPEN SURGICAL PRODUCTS, INC.NNU2024-08-07
00190776037024AvalignAvalign Technologies, Inc.NNU2023-09-28
00190776037031AvalignAvalign Technologies, Inc.NNU2023-09-28
00190776310745MILLENNIUMAvalign Technologies, Inc.NNU2023-09-28
00190776310769MILLENNIUMAvalign Technologies, Inc.NNU2023-09-28
00190776310776MILLENNIUMAvalign Technologies, Inc.NNU2023-09-28
07898506816378QuinelatoSchobell Industrial LtdaNNU2023-01-09
14026704789235PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
14026704789242PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
14026704789259PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
14026704789266PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
14026704789273PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
14026704789280PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
54026704789240PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
54026704789264PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
54026704789271PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
54026704789288PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
54026704789233PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
54026704789257PILLINGTELEFLEX INCORPORATEDNNU2022-12-08
00842331143465Novo Surgical Inc. NOVO SURGICAL, INC.NNU2022-11-11
00842331131776Novo Surgical Inc. NOVO SURGICAL, INC.NNU2022-11-10
07898506845378QuinelatoSchobell Industrial LtdaNNU2022-11-08
00887482130360Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.NNU2022-09-26
00887482038048Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.NNU2022-08-25
00887482050507Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.NNU2022-08-25
00887482054765Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.NNU2022-08-25
00887482055151Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.NNU2022-08-25
00887482055168Symmetry SchuknechtASPEN SURGICAL PRODUCTS, INC.NNU2022-08-25
00887482055175Symmetry BeebeeASPEN SURGICAL PRODUCTS, INC.NNU2022-08-25