FDA.reportPublic FDA data

Millennium

Primary DI
00190776375959
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-8450
Device description
"Tudor-Edwards Costotome 9.25"""
Published
2023-09-08
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
DWSINSTRUMENTS, SURGICAL, CARDIOVASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776375959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776375959001907763759591907763759590190776375959

GMDN Terms#

Term, Definition table
TermDefinition
Rib rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed to cut and shorten rib bones, and round the rib stumps, during a surgical intervention. It is typically made of metal with a forceps- or pliers-like design, is and designed to withstand the forces required to bite over tough/hard tissue. It is not intended for endoscopic access. 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
00884450376171One-Tie®Merit Medical Systems, Inc.DWS2026-06-06
00810220800324Adler Instrument CompanyAdler, Inc.DWS2026-06-02
00846159039931SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039948SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039955SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039962SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039979SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039986SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039993SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040005SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040012SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040029SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040036SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040043SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040050SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040067SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040074SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040081SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040098SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040104SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040111SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159040128SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-28
00846159039788SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039795SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039801SCANLAN® InstrumentSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039818SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039825SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039832SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039849SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27
00846159039856SCANLAN® ScissorsSCANLAN INTERNATIONAL INCDWS2026-05-27