FDA.reportPublic FDA data

Millennium

Primary DI
00190776409920
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-420170
Device description
"Rasp, TC, Fine Grit 1 & 2, OL 210mm (8 1/4""), TW 7mm, Double-Ended Straight Tungsten Carbide Ends. 7mm x 40mm"
Published
2025-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GACRasp, Surgical, General & Plastic Surgery
KBARasp, Nasal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GACRasp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
KBARasp, NasalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776409920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776409920001907764099201907764099200190776409920

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
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
00190776424039MillenniumAvalign Technologies, Inc.KBA2026-08-27
09348811103291INKAThe Trustee for KAISER FAMILY TRUSTKBA2026-07-31
00190776400491MillenniumAvalign Technologies, Inc.KBA2026-07-17
00190776397067MillenniumAvalign Technologies, Inc.GAC2026-07-16
G043662100BEARBear-Ent, LLCKBA2025-10-08
10888277374324MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10888277382992MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10080196382989MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10080196384983MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277374515MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377004MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377011MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377509MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277381971MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277382442MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384286MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384415MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277385863MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277386938MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277388383MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
00887482121078Symmetry DingmanASPEN SURGICAL PRODUCTS, INC.GAC2024-08-20
00887482121085Symmetry DingmanASPEN SURGICAL PRODUCTS, INC.GAC2024-08-20
10840199507518RaspKOROS U.S.A., INC.GAC2024-05-31
14026704793942PILLINGTELEFLEX INCORPORATEDGAC2022-12-08
14026704793959PILLINGTELEFLEX INCORPORATEDGAC2022-12-08
14026704793966PILLINGTELEFLEX INCORPORATEDGAC2022-12-08
14026704793973PILLINGTELEFLEX INCORPORATEDGAC2022-12-08
14026704793980PILLINGTELEFLEX INCORPORATEDGAC2022-12-08
14026704793997PILLINGTELEFLEX INCORPORATEDGAC2022-12-08
14026704798374PILLINGTELEFLEX INCORPORATEDGAC2022-12-08