FDA.reportPublic FDA data

Millennium

Primary DI
00190776434427
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-58002129
Device description
Lambotte Osteotome, curved
Published
2026-10-07
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
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776434427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776434427001907764344271907764344270190776434427

GMDN Terms#

Term, Definition table
TermDefinition
Plastic surgery osteotomeA surgical, chisel-like, instrument designed to cut and/or shape small bones and/or cartilage during plastic surgery. It is hand-held by the surgeon who will typically use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on either side with sloping curves. This device will be made of high-grade stainless steel and be used for plastic surgery procedures (e.g., to shape nasal cartilage). 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
00190776433765Millennium1-21585-112026-10-08
00190776433772Millennium1-2400712026-10-08
00190776433789Millennium1-4300842026-10-08
00190776433796Millennium1-6570502026-10-08
00190776433802Millennium1-6570512026-10-08
00190776433819Millennium1-6570532026-10-08
00190776433826Millennium1-3721INS2026-10-08
00190776433833Millennium1-13724E2026-10-08
00190776433840Millennium1-4071-32026-10-08
00190776433857Millennium1-4071-42026-10-08
00190776433864Millennium1-010-162026-10-08
00190776433871Millennium1-2176200002026-10-08
00190776434007Millennium1-GS5244762026-10-08
00190776434014Millennium1-OM460827C2026-10-08
00190776436186Millennium85-250088202026-10-08
00190776436193Millennium95-20001620062026-10-08
00190776436209Millennium85-710376932026-10-08
00190776436216Millennium85-110078822026-10-08
00190776436223Millennium85-580026702026-10-08
00190776436230Millennium85-520034232026-10-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436551MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776436568MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776436575MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776436582MilleniumAvalign Technologies, Inc.HAO2026-10-08
00190776434434MillenniumAvalign Technologies, Inc.HAO2026-10-07
00190776434342MillenniumAvalign Technologies, Inc.HAO2026-10-06
00199150032402SenSight™MEDTRONIC, INC.HAO2026-09-28
00199150032426SenSight™MEDTRONIC, INC.HAO2026-09-28
00724995303884V. MuellerSTERIS Deutschland GmbHHAO2026-09-25
04058749076042NAFehling Instruments GmbH & Co. KGHAO2026-09-21
00190776429126MillenniumAvalign Technologies, Inc.HAO2026-09-04
00190776423964MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776423995MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428068MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428075MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428082MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428099MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428105MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776428112MillenniumAvalign Technologies, Inc.HAO2026-08-27
00190776420352MillenniumAvalign Technologies, Inc.HAO2026-08-25
00190776411558MillenniumAvalign Technologies, Inc.HAO2026-08-07
00190776407537MillenniumAvalign Technologies, Inc.HAO2026-08-03
00810220800508Adler Instrument CompanyAdler, Inc.HAO2026-07-30
00810220800515Adler Instrument CompanyAdler, Inc.HAO2026-07-30
00190776407377MillenniumAvalign Technologies, Inc.HAO2026-07-28
00190776407384MillenniumAvalign Technologies, Inc.HAO2026-07-28
00190776404109MillenniumAvalign Technologies, Inc.HAO2026-07-24
00190776404000MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404017MillenniumAvalign Technologies, Inc.HAO2026-07-22
00190776404024MillenniumAvalign Technologies, Inc.HAO2026-07-22