FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776322908
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
2-23502
Device description
Sinus Curette
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
KAOCURETTE, ETHMOID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAOCurette, EthmoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776322908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776322908001907763229081907763229080190776322908

GMDN Terms#

Term, Definition table
TermDefinition
Abdominal/ENT/orthopaedic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used to explore cavities, wounds or fistulas during abdominal, ENT, and/or orthopaedic surgical interventions; it does not include stereotactic devices and is not dedicated to endoscopy. It may have a blunt bulbous, paddle-like, or pointed tip, may be single- or double-ended, and the shaft may be straight, bent or hooked. It is made of rigid or flexible metallic and/or synthetic polymer material. 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
00190776391560CONDUIT ZERO-P VA4514010602026-07-09
00190776391577CONDUIT ZERO-P VA4514010702026-07-09
00190776391584CONDUIT ZERO-P VA4514010802026-07-09
00190776391591CONDUIT ZERO-P VA4514010902026-07-09
00190776391607CONDUIT ZERO-P VA4514011002026-07-09
00190776391614CONDUIT ZERO-P VA4514011102026-07-09
00190776391621CONDUIT ZERO-P VA4514011202026-07-09
00190776391638CONDUIT ZERO-P VA4514020502026-07-09
00190776391645CONDUIT ZERO-P VA4514020602026-07-09
00190776391652CONDUIT ZERO-P VA4514020702026-07-09
00190776391669CONDUIT ZERO-P VA4514020802026-07-09
00190776391676CONDUIT ZERO-P VA4514020902026-07-09
00190776391553CONDUIT ZERO-P VA4514010502026-07-08
00190776421847Millennium1-3KF-52026-06-25
00190776421694Millennium72-24655152026-06-24
00190776421700Millennium1-1701922026-06-24
00190776421717Millennium1-1701942026-06-24
00190776421724Millennium1-77ST42026-06-24
00190776421731Millennium72-5211303C2026-06-24
00190776421748Millennium1-343003H2026-06-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776420772MillenniumAvalign Technologies, Inc.KAO2026-04-30
00190776418458MillenniumAvalign Technologies, Inc.KAO2026-03-25
00190776418465MillenniumAvalign Technologies, Inc.KAO2026-03-25
00194613108069MSI Precision Specialty InstrumentsMed Saver, Inc.KAO2025-08-01
00194613109585MSI Precision Specialty InstrumentsMed Saver, Inc.KAO2025-08-01
00194613116552MSI Precision Specialty InstrumentsMed Saver, Inc.KAO2025-08-01
00194613116569MSI Precision Specialty InstrumentsMed Saver, Inc.KAO2025-08-01
00198506001666ELMEDELMED INCORPORATEDKAO2024-04-24
G586E7411600Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
G586E7769560Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
G586E97499160Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
G586E97769230Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
G586E97769470Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
G586E97769560Novo SurgicalNOVO SURGICAL, INC.KAO2023-12-18
00842331192531Novo Surgical Inc. NOVO SURGICAL, INC.KAO2023-12-07
00842180179455ELMEDELMED INCORPORATEDKAO2023-10-12
00190776046552AvalignAvalign Technologies, Inc.KAO2023-09-28
00190776223038AvalignAvalign Technologies, Inc.KAO2023-09-28
00190776322878MILLENNIUMAvalign Technologies, Inc.KAO2023-09-28
00190776322885MILLENNIUMAvalign Technologies, Inc.KAO2023-09-28
00883475950687Flat-Blade Micro-Ringcurette φ1.0CHARMANT INC.KAO2023-09-18
00883475950694Flat-Blade Micro-Ringcurette φ1.5CHARMANT INC.KAO2023-09-18
00883475950717Micro-Curette 0.75×1.0 80deg.CHARMANT INC.KAO2023-09-18
00883475950724Micro-Curette 1.0×2.0 80deg.CHARMANT INC.KAO2023-09-18
00883475950731Micro-Curette 1.5×2.0 30deg.CHARMANT INC.KAO2023-09-18
00883475951714Micro-Curette 0.75×1.5 80deg.CHARMANT INC.KAO2023-09-18
00842962142202HNM MedicalHNM STAINLESS, LLC.KAO2023-04-17
00190776295066MillenniumAvalign Technologies, Inc.KAO2022-12-12
14026704806703PILLINGTELEFLEX INCORPORATEDKAO2022-12-08
14026704809179PILLINGTELEFLEX INCORPORATEDKAO2022-12-08