FDA.reportPublic FDA data

Millennium

Primary DI
00190776295066
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-400320
Device description
Coakley Sinus Curette, double ended, #1 & 2
Published
2022-12-12
Public version status
Update
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
00190776295066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776295066001907762950661907762950660190776295066

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal curetteA hand-held dental instrument with a sharp, hollow-ground blade, usually rounded and semicircular in cross-section, used with a pulling action to remove calculus of periodontal pockets and smooth root surfaces; it is not a gingival retraction cord packing tool. It is typically a double-ended instrument with a handle positioned centrally and is made of metal. 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
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
00190776322908MILLENNIUMAvalign 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
14026704806703PILLINGTELEFLEX INCORPORATEDKAO2022-12-08
14026704809179PILLINGTELEFLEX INCORPORATEDKAO2022-12-08