FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776293307
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
2-170593
Device description
House Cutting Block,
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
NNRBLOCK, CUTTING, ENT, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNRBlock, Cutting, Ent, Non-SterileEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776293307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776293307001907762933071907762933070190776293307

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cutting/shaping board, reusableA stiff, plastic device intended to be used as a surface to trim/contour objects or tissues (e.g., implants, transplants) in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations as a visual approximation aid. 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
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462908035evonosevonos GmbH & Co. KGNNR2026-08-21
04054462908042evonosevonos GmbH & Co. KGNNR2026-08-21
04054462908066evonosevonos GmbH & Co. KGNNR2026-08-21
04054462996810evonosevonos GmbH & Co. KGNNR2026-08-21
00810207784487Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDNNR2026-06-30
00190776421793MillenniumAvalign Technologies, Inc.NNR2026-06-24
04250676741882Cutting blockSpiggle & Theis Medizintechnik GmbHNNR2025-09-25
00190776407810MillenniumAvalign Technologies, Inc.NNR2025-08-01
00194613022167MSI Precision Specialty InstrumentsMed Saver, Inc.NNR2025-03-21
00194613030223MSI Precision Specialty InstrumentsMed Saver, Inc.NNR2025-03-21
00887482040379Symmetry TeflonASPEN SURGICAL PRODUCTS, INC.NNR2024-09-09
G043670000BEARBear-Ent, LLCNNR2024-08-15
00840183503512BR Surgical, LLCBR Surgical, LLCNNR2024-07-22
00840183527396BR Surgical, LLCBR Surgical, LLCNNR2024-07-22
00840306827525Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827532Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827549Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00840306827556Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2024-05-16
00190776320874MILLENNIUMAvalign Technologies, Inc.NNR2023-09-28
00840319753132Hayden MedicalHayden Medical, Inc.NNR2023-05-26
00842962145807HNM MEDICALHNM STAINLESS, LLC.NNR2023-04-03
14026704805690PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
54026704805698PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
14026704805683PILLINGTELEFLEX INCORPORATEDNNR2022-12-08
00840306806865Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-10
00840306806889Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-10
00842331134210Novo Surgical Inc. NOVO SURGICAL, INC.NNR2022-11-10
00840306806872Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.NNR2022-11-08
04250374712269Cutting block, glassSpiggle & Theis Medizintechnik GmbHNNR2022-09-14
04250381850169Preparation tray, stainless steelSpiggle & Theis Medizintechnik GmbHNNR2022-09-14