FDA.reportPublic FDA data

Millennium

Primary DI
00190776383602
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-3803002
Device description
Kerrison Mastoid Rongeur 2mm
Published
2024-08-20
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
JZARongeur, Mastoid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZARongeur, MastoidEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776383602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776383602001907763836021907763836020190776383602

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. 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
00194613114886MSI Precision Specialty InstrumentsMed Saver, Inc.JZA2025-08-01
00190776306991MillenniumAvalign Technologies, Inc.JZA2023-11-16
00190776296902MillenniumAvalign Technologies, Inc.JZA2022-12-12
04046826105389MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
04046826105396MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
04046826105402MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
04046826105419MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZA2020-09-24
10381780083245Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-10-24
00888118059284RONGEURKLS-Martin L.P.JZA2018-09-26
00888118059291RONGEURKLS-Martin L.P.JZA2018-09-26
00888118059307RONGEURKLS-Martin L.P.JZA2018-09-26
00888118059314RONGEURKLS-Martin L.P.JZA2018-09-26
00888118057952RONGEURKLS-Martin L.P.JZA2018-09-26
00888118057969RONGEURKLS-Martin L.P.JZA2018-09-26
00888118057976RONGEURKLS-Martin L.P.JZA2018-09-26
10381780076810Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780076827Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780076834Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780076841Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-09-17
10381780198154Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-03-27
M2743803051Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-03-27
10381780445326Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445333Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445418Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445425Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445432Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
10381780445449Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH1912300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH1912320Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05
H834MH198440Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZA2018-02-05