FDA.reportPublic FDA data

Millennium

Primary DI
00190776415174
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-GS824304C
Device description
"Kirschner Bow 9 1/2"""
Published
2025-12-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSTApparatus, Traction, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSTApparatus, Traction, Non-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776415174PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776415174001907764151741907764151740190776415174

GMDN Terms#

Term, Definition table
TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. 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
00842430116728TRAPEZE ARM ASSEMBLY, PATIENT HELPERMIZUHO ORTHOPEDIC SYSTEMS, INC.HST2025-07-28
00887482122723Symmetry LoganASPEN SURGICAL PRODUCTS, INC.HST2024-08-20
00615521004712ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004736ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004750ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004828ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004842ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00840277130495Innomed, Inc.INNOMED, INC.HST2024-05-09
00860011457800IHNIHN, Inc.HST2024-02-07
00860011457817IHNIHN, Inc.HST2024-02-07
10860011457807IHNIHN, Inc.HST2024-02-07
10860011457814IHNIHN, Inc.HST2024-02-07
00840277129444Innomed,Inc.INNOMED, INC.HST2023-12-19
00840277129451Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129468Innomed,Inc.INNOMED, INC.HST2023-12-19
00840277129475Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129482Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129499Innomed, Inc.INNOMED, INC.HST2023-12-19
00724995225544NASTERIS CORPORATIONHST2023-11-17
00860011173618AFTHILL LABORATORIES CO.HST2023-10-23
00860011173625Air Drop AFTHILL LABORATORIES CO.HST2023-10-23
00860001452570Air Flex IIHILL LABORATORIES CO.HST2023-10-16
04719871180167EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HST2023-08-24
04719871180365EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HST2023-08-24
00615521001490ALLENHILL-ROM, INC.HST2023-07-31
00615521001506ALLENHILL-ROM, INC.HST2023-07-31
00615521012823ALLENHILL-ROM, INC.HST2023-07-31
00615521021160ALLENHILL-ROM, INC.HST2023-07-31
00615521021177ALLENHILL-ROM, INC.HST2023-07-31
00615521021184ALLENHILL-ROM, INC.HST2023-07-31