FDA.reportPublic FDA data

Millennium

Primary DI
00190776395537
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-20093687
Device description
Bellucci Ear Suction Tube
Published
2026-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZFTube, Ear Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776395537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776395537001907763955371907763955370190776395537

GMDN Terms#

Term, Definition table
TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes 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
18772891096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423827MillenniumAvalign Technologies, Inc.JZF2026-08-26
04054462901975evonosevonos GmbH & Co. KGJZF2026-08-21
04054462901982evonosevonos GmbH & Co. KGJZF2026-08-21
04054462901999evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902002evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902019evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902026evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902033evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902040evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902057evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902064evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902088evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902095evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902101evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902118evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902125evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902132evonosevonos GmbH & Co. KGJZF2026-08-21
04054462902149evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904396evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904402evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904419evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904426evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904433evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904440evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904457evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904471evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904495evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904501evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904518evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904525evonosevonos GmbH & Co. KGJZF2026-08-21