FDA.reportPublic FDA data

Millennium

Primary DI
00190776419660
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-23057787
Device description
Brophy Tenacula Sharp Hook
Published
2026-08-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDGHook, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776419660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776419660001907764196601907764196600190776419660

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18772891096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27
00190776424015Millennium85-120121642026-08-27
00190776424022Millennium85-210153622026-08-27
00190776424039Millennium85-220037062026-08-27
00190776424046Millennium85-720391342026-08-27
00190776424084Millennium85-640064342026-08-27
00190776424091Millennium85-760796022026-08-27
00190776424107Millennium85-770087842026-08-27
00190776424114Millennium85-120079002026-08-27
00190776424121Millennium85-660175762026-08-27
00190776424138Millennium85-510124832026-08-27
00190776424145Millennium85-720426312026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B033K941409" Nerve HookKapp Surgical Instrument Co.GDG2026-08-27
00810158215955PRINCETONPrinceton Medical Group, Inc.GDG2026-08-25
10850067560323MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560330MaxRetractSurgical Principals, IncGDG2026-08-25
10850067560347MaxRetractSurgical Principals, IncGDG2026-08-25
00190776417161MillenniumAvalign Technologies, Inc.GDG2026-08-19
00190776417079MillenniumAvalign Technologies, Inc.GDG2026-08-18
00190776422219MillenniumAvalign Technologies, Inc.GDG2026-07-31
00190776407346MillenniumAvalign Technologies, Inc.GDG2026-07-28
B382SD907072080Surgical DirectSurgical Direct, Inc.GDG2026-07-27
B382SD907072090Surgical DirectSurgical Direct, Inc.GDG2026-07-27
B382SD9147096600Surgical DirectSurgical Direct, Inc.GDG2026-07-27
B382SD9147096610Surgical DirectSurgical Direct, Inc.GDG2026-07-27
00850088713176PRINCETONPrinceton Medical Group, Inc.GDG2026-07-23
00840183531232BR Surgical, LLCBR Surgical, LLCGDG2026-07-21
B382SD907505200Surgical DirectSurgical Direct, Inc.GDG2026-07-17
B382SD907505210Surgical DirectSurgical Direct, Inc.GDG2026-07-17
00190776395674MillenniumAvalign Technologies, Inc.GDG2026-07-14
00810158216136PRINCETONPrinceton Medical Group, Inc.GDG2026-06-23
B7685252430Buxton BioMedicalBuxton Biomedical IncGDG2026-06-05
G383S1061WM3245624S7SURJEXSURJEXGDG2026-05-31
00810055258734Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258741Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258758Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258765Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258772Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258789Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258796Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258802Surgical DesignSurgical Design, Inc.GDG2026-05-29
00810055258819Surgical DesignSurgical Design, Inc.GDG2026-05-29