FDA.reportPublic FDA data

Millennium

Primary DI
00190776307042
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-407609
Device description
"Cohen Elevator 9 12"" Blunt"
Published
2023-11-16
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
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776307042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776307042001907763070421907763070420190776307042

GMDN Terms#

Term, Definition table
TermDefinition
ENT elevatorA hand-held, manually-operated, surgical instrument used to lift, position or pry anatomical structures or surgical material during ear/nose/throat (ENT) surgery. It may be a single or a double-ended device with a blunted blade or hook of various shapes with no cutting edges at the distal working end(s) and a handle positioned centrally or at the proximal end. Its shape and size depends upon the intended use, e.g., a blunt antrum, a rhinology or septum elevator, a strong nasal fracture elevator, or a specially designed ear elevator. It is usually made of high-grade stainless steel. 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
G4251902480My MedicalMy Medical Store LLCGEG2026-05-04
10381780503224Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2020-10-01
10381780503248Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2020-10-01
10381780503361Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2020-10-01
10381780503378Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2020-10-01
10381780503606Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2020-10-01
10649111225628SklarSKLAR CORPORATIONGEG2019-08-02
10649111452826SklarSKLAR CORPORATIONGEG2019-05-13
10381780495888Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-10-24
10381780509523Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-10-23
10381780499671Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-18
10381780499688Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-18
10381780499695Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-18
10381780499701Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-18
10381780499718Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-18
10381780506522Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-12
10381780506539Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-09-12
10381780487791Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-20
10381780487838Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-20
10381780487982Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-20
10381780423997Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780424116Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780445517Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-08-16
10381780407706Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-03
10381780401254Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401261Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401278Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401285Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401292Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780409779Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02