FDA.report

MILLENNIUM

Primary DI
00190776339142
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
0-46654
Device description
Putti Bone Rasp, double ended,
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GACRASP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GACRasp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776339142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776339142001907763391421907763391420190776339142

GMDN Terms

TermDefinition
Nasal file/raspA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth at the working end(s) designed to remove and profile the cartilage/bone of the nose during ear/nose/throat (ENT) or plastic surgery. It is typically a one-piece instrument 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 made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10705034577067N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577074N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577081N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577104N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577555N/ADEPUY SPINE, LLCGAC2026-02-05
03662663083577ActivLHighridge Medical, LLCGAC2026-02-03
00842078102275Omni PlatingEXTREMITY MEDICAL, LLCGAC2026-01-21
00842078102329Omni PlatingEXTREMITY MEDICAL, LLCGAC2026-01-21
00810207783558Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783565Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783572Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783589Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783596Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783602Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783619Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783626Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783633Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783640Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783657Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783664Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783671Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00190776411367MillenniumAvalign Technologies, Inc.GAC2025-09-22
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B356FF131050American MedicalsAmerican MedicalsGAC2025-08-16
00190776406875MillenniumAvalign Technologies, Inc.GAC2025-07-24
00190776406578MillenniumAvalign Technologies, Inc.GAC2025-07-22
00190776406585MillenniumAvalign Technologies, Inc.GAC2025-07-22