FDA.reportPublic FDA data

Millennium

Primary DI
00190776395681
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-67037208
Device description
Janetta Duckbill Elevator
Published
2026-07-14
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
00190776395681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776395681001907763956811907763956810190776395681

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
00190776395353Millennium85-220117852026-07-14
00190776395360Millennium85-120P088052026-07-14
00190776395445Millennium85-610149882026-07-14
00190776395469Millennium85-200067112026-07-14
00190776395476Millennium85-760826282026-07-14
00190776395483Millennium85-620343252026-07-14
00190776395490Millennium85-160514552026-07-14
00190776395506Millennium85-780041542026-07-14
00190776395513Millennium85-780041492026-07-14
00190776395520Millennium85-640030002026-07-14
00190776395537Millennium85-200936872026-07-14
00190776395544Millennium85-780027742026-07-14
00190776395551Millennium85-780942452026-07-14
00190776395568Millennium85-200771592026-07-14
00190776395575Millennium85-431123682026-07-14
00190776395582Millennium85-431120402026-07-14
00190776395599Millennium85-780694382026-07-14
00190776395605Millennium85-520029402026-07-14
00190776395629Millennium85-200771522026-07-14
00190776395636Millennium85-320P072422026-07-14

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Primary DI, Brand, Company table
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