FDA.reportPublic FDA data

Millennium

Primary DI
00190776438012
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-020184
Device description
Converse Guarded Osteotome 7" 12mm Wide
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776438012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776438012001907764380121907764380120190776438012

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776437909Millennium72-2415172026-11-05
00190776437916Millennium72-2415182026-11-05
00190776437923Millennium72-52205523I2026-11-05
00190776437930Millennium1-67395352026-11-05
00190776437947Millennium1-67395452026-11-05
00190776437954Millennium1-6739515M2026-11-05
00190776437961Millennium1-6739525M2026-11-05
00190776437978Millennium72-4020402026-11-05
00190776437985Millennium92-C02052026-11-05
00190776437992Millennium1-0903972026-11-05
00190776438005Millennium1-38883072026-11-05
00190776439880Millenium85-641036092026-11-05
00190776439897Millenium85-641036172026-11-05
00190776440879Millenium85-641036292026-11-05
00190776437473Millennium1-290322402026-11-04
00190776437480Millennium1-290323402026-11-04
00190776437497Millennium1-FO455R2026-11-04
00190776437503Millennium1-CH20532026-11-04
00190776437510Millennium92-C02452026-11-04
00190776437527Millennium1-71015044T2026-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776438005MillenniumAvalign Technologies, Inc.HWM2026-11-05
00190776437589MillenniumAvalign Technologies, Inc.HWM2026-11-04
08809974816141Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWM2026-11-03
G383S1093WM3265403X2SURJEXSURJEXHWM2026-10-31
G383S1093WM3265406X8SURJEXSURJEXHWM2026-10-31
G383S1093WM3265412X3SURJEXSURJEXHWM2026-10-31
00840329838836BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-10-30
00192896123946Micro OsteotomeSONTEC INSTRUMENTS, INC.HWM2026-10-27
00190776435516MillenniumAvalign Technologies, Inc.HWM2026-10-20
00190776435523MillenniumAvalign Technologies, Inc.HWM2026-10-20
00190776435592MillenniumAvalign Technologies, Inc.HWM2026-10-20
00190776437671MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776437732MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776437817MilleniumAvalign Technologies, Inc.HWM2026-10-20
00190776435127MillenniumAvalign Technologies, Inc.HWM2026-10-15
00190776435134MillenniumAvalign Technologies, Inc.HWM2026-10-15
00840277133915Innomed, Inc.INNOMED, INC.HWM2026-10-09
00190776434007MillenniumAvalign Technologies, Inc.HWM2026-10-08
00190776436261MillenniumAvalign Technologies, Inc.HWM2026-10-08
G141548807040Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141548807060Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141549966080Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
G141646640020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-10-07
B7687715080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.HWM2026-10-06
00190776432935MillenniumAvalign Technologies, Inc.HWM2026-09-30
00840329838676BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
00840329838683BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
G14164746930Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
G141647481020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
00190776432812MillenniumAvalign Technologies, Inc.HWM2026-09-29