FDA.reportPublic FDA data

Millennium

Primary DI
00190776378448
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
2-1685 S14
Device description
"Paparella Fenestrometer, #13, TW 4mm, SL 73mm, OL 166mm (6 1/2"")"
Published
2023-11-13
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
JYJGAUGE, MEASURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYJGauge, MeasuringEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776378448PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776378448001907763784481907763784480190776378448

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
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
04054462906819evonosevonos GmbH & Co. KGJYJ2026-08-21
04054462908080evonosevonos GmbH & Co. KGJYJ2026-08-21
04054462907588evonosevonos GmbH & Co. KGJYJ2026-08-18
04054462907595evonosevonos GmbH & Co. KGJYJ2026-08-18
04054462907601evonosevonos GmbH & Co. KGJYJ2026-08-18
04054462908097evonosevonos GmbH & Co. KGJYJ2026-08-18
09348811109439INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-05-29
14250368861062KURZ Meter incl. TrayHeinz Kurz GmbHJYJ2026-05-21
14250368862557Sizer OMEGA CONNECTORHeinz Kurz GmbHJYJ2026-05-21
14250368865404AC Sizer System PartialHeinz Kurz GmbHJYJ2026-05-21
14250368865503AC Sizer System TotalHeinz Kurz GmbHJYJ2026-05-21
09348811109408INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109415INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109446INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-03-18
09348811109422INKAThe Trustee for KAISER FAMILY TRUSTJYJ2025-12-01
00844505014700SKULL BASEGrace Medical, Inc.JYJ2025-09-26
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.JYJ2025-07-17
00844505014649NYTEBYTEGrace Medical, Inc.JYJ2025-07-02
00757770501274Bausch + LombBausch & Lomb IncorporatedJYJ2025-06-03
00194613116965MSI Precision Specialty InstrumentsMed Saver, Inc.JYJ2025-03-21
00848253004006Blom-Singer® Nasal Septal Perforation Sizing ToolFreudenberg Medical, LLCJYJ2025-03-14
00840183527501BR Surgical, LLCBR Surgical, LLCJYJ2024-11-26
00887482114223Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.JYJ2024-08-20
00887482113387Symmetry AustinASPEN SURGICAL PRODUCTS, INC.JYJ2024-08-12
00844505014328BENSON UNIVERSAL IMPLANT SIZERGrace Medical, Inc.JYJ2023-09-27
00190776289232MillenniumAvalign Technologies, Inc.JYJ2023-06-23
00842331168475Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-13
00842331131288Novo Surgical Inc. NOVO SURGICAL, INC.JYJ2022-11-10
04250381854891Castroviejo nasal caliperSpiggle & Theis Medizintechnik GmbHJYJ2022-09-16
04250676733726Joseph placing instrumentSpiggle & Theis Medizintechnik GmbHJYJ2022-09-16