FDA.reportPublic FDA data

Millennium

Primary DI
00190776397128
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-64004121
Device description
Ejector Kerrison
Published
2026-07-16
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
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776397128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776397128001907763971281907763971280190776397128

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. 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
false
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
00190776397050Millennium85-160P208832026-07-16
00190776397067Millennium85-530366172026-07-16
00190776397074Millennium85-720391422026-07-16
00190776397081Millennium14-50052026-07-16
00190776397104Millennium85-770498932026-07-16
00190776397111Millennium85-230675902026-07-16
00190776397135Millennium85-710186192026-07-16
00190776397142Millennium85-300243682026-07-16
00190776397159Millennium85-780096162026-07-16
00190776397166Millennium85-900102152026-07-16
00190776397173Millennium85-520023162026-07-16
00190776397180Millennium85-528137762026-07-16
00190776397197Millennium85-520111272026-07-16
00190776397463Millennium85-140308682026-07-16
00190776398484Millennium85-800001202026-07-16
00190776398651Millennium85-590P015832026-07-16
00190776398668Millennium85-710378692026-07-16
00190776398682Millennium85-710369342026-07-16
00190776398699Millennium85-710374012026-07-16
00190776398705Millennium85-780893552026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395520MillenniumAvalign Technologies, Inc.HAE2026-07-14
04255968300020VitalitecVitalitec International Medizintechnik GmbHHAE2026-06-23
07613327651676mild Device KitSTRYKER CORPORATIONHAE2024-11-22
B235MDK00020mild Device KitSTRYKER CORPORATIONHAE2024-06-19
G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
04046955074624AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074631AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074648AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074655AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074662AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074716AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074723AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074730AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074792AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074808AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074815AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074822AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074914AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074921AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074938AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074945AESCULAPAESCULAP, INC.HAE2019-04-30
04046955074952AESCULAPAESCULAP, INC.HAE2019-04-30
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