FDA.reportPublic FDA data

Millennium

Primary DI
00190776385774
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-60001610
Device description
"Gigli Saw Blade, OL 760mm (30"")"
Published
2024-05-09
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
GDRSaw, Manual And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDRSaw, Manual And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776385774PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776385774001907763857741907763857740190776385774

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical saw blade, rigidA flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a rigid manual hand saw used for cutting bone/tissue when a directional pressure is applied. This device is designed with the cutting teeth arranged in a straight line along the cutting edge and which cuts when the blade is manually powered in a back and forth motion by the user. 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
00190776432256Millennium1-9317432026-09-24
00190776432263Millennium1-7023075732026-09-24
00190776432270Millennium1-7023075742026-09-24
00190776432287Millennium1-2245100402026-09-24
00190776432294Millennium1-2810170002026-09-24
00190776432300Millennium100-S03285FGD202026-09-24
00190776432317Millennium100-S03286FGD452026-09-24
00190776432324Millennium72-586006C2026-09-24
00190776432331Millennium1-831100202026-09-24
00190776432348Millennium72-52515962026-09-24
00190776432355Millennium1-9314972026-09-24
00190776432362Millennium1-4751872026-09-24
00190776432379Millennium1-CH26102026-09-24
00190776432386Millennium72-52103236C32026-09-24
00190776432393Millennium72-241180KB2026-09-24
00190776432409Millennium1-CP4520022026-09-24
00190776432416Millennium72-52505182026-09-24
00190776432423Millennium1-GS4259402026-09-24
00190776432430Millennium100-S02681TR2026-09-24
00190776432447Millennium100-S02683TR2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411589MillenniumAvalign Technologies, Inc.GDR2026-08-07
B382SD9140251010Surgical DirectSurgical Direct, Inc.GDR2026-07-28
08403207009517Anmuth Medical InternationalAnmuth Medical International, LLCGDR2025-06-09
08403207009579Anmuth Medical InternationalAnmuth Medical International, LLCGDR2025-06-09
04049047061984GimmiGimmi GmbHGDR2025-05-20
04049047062080GimmiGimmi GmbHGDR2025-05-20
00810123208593Adler Instrument CompanyAdler, Inc.GDR2025-02-12
04049197537292RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-10-16
04049197499248RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197499255RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197499262RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197149983RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197149990RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150002RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150125RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150163RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197205146RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197205153RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
00842517107533Karl SchumacherKarl Schumacher Dental, LLCGDR2024-02-28
00842517107540Karl SchumacherKarl Schumacher Dental, LLCGDR2024-02-28
00888515192003BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192010BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192027BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192034BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192058BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192065BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192072BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192089BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192096BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515201927BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28