FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776347277
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
12-463159
Device description
Cervical Micro 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
GZXINSTRUMENT, MICROSURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776347277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776347277001907763472771907763472770190776347277

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
G223150101200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCGZX2023-06-15
10381780225317Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225447Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225454Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225638Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-09-12
10381780225393Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-09
10381780194354Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194361Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194378Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194385Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194392Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194408Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194415Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194422Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780167259Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780167273Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185505Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185536Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185543Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185550Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185598Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185604Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185611Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185628Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185666Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185673Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185680Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185697Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185703Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27
10381780185710Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-03-27