FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776322915
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
31-3714285
Device description
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
KAPCURETTE, NASAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAPCurette, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776322915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776322915001907763229151907763229150190776322915

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose curetteA hand-held manual surgical instrument designed for scraping and/or excising tissue from a wide variety of anatomical sites, and includes at least one non-dermal application (i.e., non-dedicated). It is typically made of high-grade stainless steel, available in a variety of shapes and sizes, and has an appropriately-shaped distal end (e.g., cup-, ring-, spoon-like). This is a single-use 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
09348811100368INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-28
09348811100382INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
09348811100979INKAThe Trustee for KAISER FAMILY TRUSTKAP2025-11-25
00757770668410Bausch + LombBausch & Lomb IncorporatedKAP2025-08-05
00757770684618Bausch + LombBausch & Lomb IncorporatedKAP2025-08-05
00757770422944Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770424764Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770425716Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770431182Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770434046Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770434640Bausch + LombBausch & Lomb IncorporatedKAP2025-07-31
00757770403004Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770406562Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770410859Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770411962Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770418589Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770419845Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770420506Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770422630Bausch + LombBausch & Lomb IncorporatedKAP2025-07-28
00757770402779Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770403776Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770404483Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770406586Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770420360Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00757770423088Bausch + LombBausch & Lomb IncorporatedKAP2024-11-20
00887482116203Symmetry PaparellaASPEN SURGICAL PRODUCTS, INC.KAP2024-09-05
00887482119358Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KAP2024-09-05
00194613068608MSI Precision Specialty InstrumentsMed Saver, Inc.KAP2024-08-15
00840183527327BR Surgical, LLCBR Surgical, LLCKAP2024-07-16
00840183522537BR Surgical, LLCBR Surgical, LLCKAP2024-06-03