FDA.reportPublic FDA data

Millennium

Primary DI
00190776331740
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
2-10006
Device description
"Rasp, TC, coarse grit 5 and 6, OL 215mm (8 1/2""), tip length 35mm"
Published
2023-11-13
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
KBARASP, NASAL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776331740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776331740001907763317401907763317400190776331740

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
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
00810220800256Adler Instrument CompanyAdler, Inc.KBA2026-05-26
24026704941685PILLINGTELEFLEX INCORPORATEDKBA2026-02-11
09348811102744INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103246INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103253INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
09348811103260INKAThe Trustee for KAISER FAMILY TRUSTKBA2025-11-28
04250676732187Nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-25
04250676732194Nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-25
04250676740229Joseph nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-19
04250676740236Joseph nasal raspSpiggle & Theis Medizintechnik GmbHKBA2025-09-19
00194613032586MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032616MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032623MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032647MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032661MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613032685MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613047887MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613110314MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613110321MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613111236MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613116941MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613117115MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613117849MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613119737MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613121662MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00194613121679MSI Precision Specialty InstrumentsMed Saver, Inc.KBA2025-08-01
00757770407002Bausch + LombBausch & Lomb IncorporatedKBA2025-07-31
00757770409792Bausch + LombBausch & Lomb IncorporatedKBA2025-07-31
00757770413669Bausch + LombBausch & Lomb IncorporatedKBA2025-07-31
00757770413966Bausch + LombBausch & Lomb IncorporatedKBA2025-07-31