FDA.reportPublic FDA data

Millennium

Primary DI
00190776205270
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
15-8591MK
Device description
Cutting Forceps biopsy cups horizontal
Published
2021-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776205270PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776205270001907762052701907762052700190776205270

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
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
00190776407520MillenniumAvalign Technologies, Inc.HTZ2026-07-31
03701089527491AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527507AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527514AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527521AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527583AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527590AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527606AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527682AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527699AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527705AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527712AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527729AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527736AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527743AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527750AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527767AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527774AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527781AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527798AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527804AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527811AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527828AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527835AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527842AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527859AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089540780AMPLITUDEAMPLITUDE SASHTZ2026-07-29
00190776402129MillenniumAvalign Technologies, Inc.HTZ2026-07-19
M697X07901151Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.HTZ2026-07-08
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18