FDA.reportPublic FDA data

Millennium

Primary DI
00190776400354
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-64004877
Device description
Micro Kerrison Shaft Only
Published
2026-07-17
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
00190776400354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776400354001907764003541907764003540190776400354

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type clinical chemistry analyte profile IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.

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
00190776400255Millennium85-770394842026-07-17
00190776400279Millennium85-612145882026-07-17
00190776400286Millennium85-650123442026-07-17
00190776400293Millennium85-650124292026-07-17
00190776400309Millennium85-530182002026-07-17
00190776400316Millennium85-640256632026-07-17
00190776400323Millennium85-642056792026-07-17
00190776400330Millennium85-140309902026-07-17
00190776400347Millennium85-500031652026-07-17
00190776400361Millennium85-140193092026-07-17
00190776400378Millennium85-710076432026-07-17
00190776400385Millennium85-710041182026-07-17
00190776400392Millennium85-430112722026-07-17
00190776400408Millennium12-8015252026-07-17
00190776400415Millennium12-8015242026-07-17
00190776400422Millennium85-220009752026-07-17
00190776400439Millennium85-220009792026-07-17
00190776400446Millennium85-230835912026-07-17
00190776400453Millennium85-170101252026-07-17
00190776400477Millennium85-406412342026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776400538MillenniumAvalign Technologies, Inc.HAE2026-07-19
00190776400316MillenniumAvalign Technologies, Inc.HAE2026-07-17
00190776400323MillenniumAvalign Technologies, Inc.HAE2026-07-17
00810220800478Adler Instrument CompanyAdler, Inc.HAE2026-07-17
00190776397128MillenniumAvalign Technologies, Inc.HAE2026-07-16
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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