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
00190776435479Millennium1-510489L2026-10-20
00190776435486Millennium1-FK177R2026-10-20
00190776435493Millennium72-5255006452026-10-20
00190776435509Millennium1-3910152026-10-20
00190776435516Millennium1-750750202026-10-20
00190776435523Millennium1-750750402026-10-20
00190776435530Millennium1-636012026-10-20
00190776435547Millennium72-5255540SL2026-10-20
00190776435554Millennium1-9356482026-10-20
00190776435561Millennium72-522056116202026-10-20
00190776435578Millennium1-225402L2026-10-20
00190776435585Millennium1-225402R2026-10-20
00190776435592Millennium1-6020222026-10-20
00190776435608Millennium1-6020172026-10-20
00190776436612Millenium85-630049412026-10-20
00190776436629Millenium85-110109462026-10-20
00190776436636Millenium85-520062822026-10-20
00190776436643Millenium85-520029442026-10-20
00190776436674Millenium85-420339012026-10-20
00190776436681Millenium85-520234622026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436674MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776436704MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776437657MilleniumAvalign Technologies, Inc.DWS2026-10-20
00190776437770MillenniumAvalign Technologies, Inc.DWS2026-10-20
00190776437794MillenniumAvalign Technologies, Inc.DWS2026-10-20
03661219455073LANDANGERLANDANGERDWS2026-10-19
03661219008224LANDANGERLANDANGERDWS2026-10-12
03661219389811DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219510024DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525486DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525509DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525523DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525547DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525561DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525585DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525608DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525943DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525950DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525967DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525974DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219525981DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
03661219527442DELACROIX-CHEVALIERLANDANGERDWS2026-10-12
04058749009897NAFehling Instruments GmbH & Co. KGDWS2026-10-12
04058749125931NAFehling Instruments GmbH & Co. KGDWS2026-10-12
03661219320265DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219438601DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219442943DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
03661219528388DELACROIX-CHEVALIERLANDANGERDWS2026-10-11
00190776434236MillenniumAvalign Technologies, Inc.DWS2026-10-09
00190776436216MillenniumAvalign Technologies, Inc.DWS2026-10-08