FDA.reportPublic FDA data

Millennium

Primary DI
00190776407407
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-67033847
Device description
Landolt-Reulen Hook
Published
2026-07-31
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
GZXInstrument, Microsurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776407407PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776407407001907764074071907764074070190776407407

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
00190776407537Millennium85-900114502026-08-03
00190776407544Millennium85-220032892026-08-03
00190776407551Millennium85-200771242026-08-03
00190776407568Millennium85-440133392026-08-03
00190776408619Millennium9-8123302026-08-03
00190776408626Millennium85-500021432026-08-03
00190776408633Millennium85-528030162026-08-03
00190776408640Millennium85-668484472026-08-03
00190776408664Millennium85-650059602026-08-03
00190776408671Millennium85-220140482026-08-03
00190776408688Millennium85-780029742026-08-03
00190776408695Millennium85-600048132026-08-03
00190776408718Millennium85-250056502026-08-03
00190776408725Millennium85-600098002026-08-03
00190776408732Millennium85-160225992026-08-03
00190776408749Millennium85-710033452026-08-03
00190776408756Millennium85-620453222026-08-03
00190776408763Millennium85-120145262026-08-03
00190776408817Millennium85-310P447392026-08-03
00190776408824Millennium85-710026302026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776408640MillenniumAvalign Technologies, Inc.GZX2026-08-03
00190776407414MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776422271MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407322MillenniumAvalign Technologies, Inc.GZX2026-07-28
00190776404093MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404116MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404123MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404130MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404086MillenniumAvalign Technologies, Inc.GZX2026-07-22
00190776400613MillenniumAvalign Technologies, Inc.GZX2026-07-21
00190776403386MillenniumAvalign Technologies, Inc.GZX2026-07-21
00650551006978PMT® SUCTION INSTRUMENTSPMT CORPORATIONGZX2026-07-20
00190776402099MillenniumAvalign Technologies, Inc.GZX2026-07-19
00190776400408MillenniumAvalign Technologies, Inc.GZX2026-07-17
00190776400415MillenniumAvalign Technologies, Inc.GZX2026-07-17
00190776395681MillenniumAvalign Technologies, Inc.GZX2026-07-14
00846159039672SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039689SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039696SCANLAN® ScissorsSCANLAN INTERNATIONAL INCGZX2026-05-27
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