FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776319571
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
2-170570B
Device description
Measuring Rod,
Published
2023-09-28
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
JYZROD, MEASURING EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYZRod, Measuring EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776319571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776319571001907763195711907763195710190776319571

GMDN Terms#

Term, Definition table
TermDefinition
Nasal depth gauge, reusableA manual instrument designed for introduction into and measurement of the nasal cavities and paranasal sinuses during diagnostic and/or surgical procedures. It typically consists of a hand-held, slender, rod-like metallic device with a fine blunt distal end; the device usually includes rings (e.g., 3, 4, 5 mm) with calibrated diameters at its distal end to perform the measurements. 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
04250676726889Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2025-09-24
04250676726865Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2024-11-11
00887482047644Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113790Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113806Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00887482113813Symmetry HouseASPEN SURGICAL PRODUCTS, INC.JYZ2024-08-12
00842331191091Novo SurgicalNOVO SURGICAL, INC.JYZ2023-12-18
G586E7214780Novo SurgicalNOVO SURGICAL, INC.JYZ2023-12-18
00190776044275AvalignAvalign Technologies, Inc.JYZ2023-11-13
00190776044299AvalignAvalign Technologies, Inc.JYZ2023-09-28
00190776319588MILLENNIUMAvalign Technologies, Inc.JYZ2023-09-28
G043655090BEARBear-Ent, LLCJYZ2023-08-08
G043655100BEARBear-Ent, LLCJYZ2023-08-08
00190776369729MillenniumAvalign Technologies, Inc.JYZ2023-02-22
14026704805188PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805195PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805201PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805193PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805186PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
54026704805209PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
14026704805218PILLINGTELEFLEX INCORPORATEDJYZ2022-12-08
00842331174711Novo Surgical Inc. NOVO SURGICAL, INC.JYZ2022-11-14
00842331179525Novo Surgical Inc. NOVO SURGICAL, INC.JYZ2022-11-14
00840343700584Gen2SURGIX MEDICAL LLCJYZ2022-10-18
G277G2E9009610Gen2SURGIX MEDICAL LLCJYZ2022-09-23
04250676726872Caversaccio Tympano SizerSpiggle & Theis Medizintechnik GmbHJYZ2022-09-12
00190776044282AvalignAvalign Technologies, Inc.JYZ2021-11-03
00190776044305AvalignAvalign Technologies, Inc.JYZ2021-11-03
B351B655100BEARMytamed, Inc.JYZ2021-11-01
B351B655110BEARMytamed, Inc.JYZ2021-11-01