FDA.reportPublic FDA data

Millennium

Primary DI
00190776407858
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-300305
Device description
GIERTA-STILLE RIB SHEARS 250MM
Published
2025-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZTCutter, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776407858PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776407858001907764078581907764078580190776407858

GMDN Terms#

Term, Definition table
TermDefinition
Rib guillotineA manually-operated surgical instrument designed to cut transversely (i.e., transect) one or more ribs during a surgical procedure that requires the opening of the thoracic cavity. It typically consists of a robust metal frame through which runs a sliding blade which is moved by the device operator (e.g., through a squeezing action). It is made of high-grade stainless steel and may be available in various shapes and sizes. 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
00841435119062TecometTECOMET INC.FZT2026-06-08
G149TBSB7890TBS BASICSACME ENTERPRISE.FZT2026-05-21
14250368861550KURZ Precise Cartilage Knife SetHeinz Kurz GmbHFZT2026-05-21
08717903490594Humeca MAX MesherHumeca B.V.FZT2026-03-31
05010058084346InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-12-16
00192896122499Cartilage Graft CutterSONTEC INSTRUMENTS, INC.FZT2025-11-21
03662663113151Virage OCT Spinal Fixation SystemHighridge Medical, LLCFZT2025-11-12
04049197556552RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZT2025-10-15
05010058080492InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-06-23
05010058080836InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-06-23
10649111400117Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
10649111400124Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
10649111400131Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
E896294920SCHWERTA. Schweickhardt GmbH & Co. KGFZT2025-05-22
05010058081987InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-05-21
05010058999749InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-05-21
10649111078910Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111079092Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111488115Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111488122Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
00850037506262MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-09-18
00850037506231MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00850037506248MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00850037506255MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00714646000781SutureOutBionix, LLCFZT2024-04-23
00714646001184SutureOutBionix, LLCFZT2024-04-23
10197106247327CARDINAL HEALTHCardinal Health 200, LLCFZT2023-09-14
00818069010997TecometTECOMET INC.FZT2023-08-10
05010058070837InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08
05010058070950InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08