FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776291853
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
0-46310
Device description
Lambotte Osteotome, straight
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00190776291853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776291853001907762918531907762918530190776291853

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a 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 both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586N93065370Novo SurgicalNOVO SURGICAL, INC.HAO2024-02-22
G586N93065380Novo SurgicalNOVO SURGICAL, INC.HAO2024-02-22
G28435301ScrewdriverNeurovention LLCHAO2022-06-21
07613327262322XIAStryker CorporationHAO2019-11-21
07613327264432XIA 4.5Stryker CorporationHAO2019-11-21
07613327264951XIA 3Stryker CorporationHAO2019-11-21
07613327271447OASYSStryker CorporationHAO2019-11-21
07613327276176RADIUSStryker CorporationHAO2019-11-21
07613327263787RELIANCE LITeStryker CorporationHAO2019-11-20
07613327263923RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265897RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265910RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265934RELIANCE LITeStryker CorporationHAO2019-11-20
07613327266016RELIANCE LITeStryker CorporationHAO2019-11-20
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