FDA.reportPublic FDA data

Millennium

Primary DI
00190776413064
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-19190
Device description
LATHBURY APPLICATOR 5.5 TRIANGULAR TIP
Published
2025-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776413064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776413064001907764130641907764130640190776413064

GMDN Terms#

Term, Definition table
TermDefinition
ENT powder applicatorAn applicator designed to utilize blowing air, typically through the use of a hand-operated bulb, to administer powdered medication to the ear, nose, or oral cavity/throat during an ear/nose/throat (ENT) procedure or treatment. 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
00190776405960Millennium85-100042892026-07-28
00190776405977Millennium85-230675282026-07-28
00190776407285Millennium85-250064102026-07-28
00190776407292Millennium85-250050002026-07-28
00190776407308Millennium85-070840962026-07-28
00190776407315Millennium85-510045332026-07-28
00190776407322Millennium85-670337972026-07-28
00190776407346Millennium85-140080412026-07-28
00190776407353Millennium85-220032842026-07-28
00190776407360Millennium85-420461622026-07-28
00190776407377Millennium85-671351502026-07-28
00190776407384Millennium85-580058692026-07-28
00190776422080Millennium72-37180032026-07-28
00190776422158Millennium1-2701802026-07-28
00190776422165Millennium72-3217125I2026-07-28
00190776422172Millennium1-20524572026-07-28
00190776422189Millennium1-633522026-07-28
00190776422196Millennium1-3202392026-07-28
00190776422202Millennium1-ASIM123205262026-07-28
00190776404093Millennium85-670332562026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506093593ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093777ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093807ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
00198506093814ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-29
B382SD9200321000Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321060Surgical DirectSurgical Direct, Inc.LRC2026-07-29
B382SD9200321070Surgical DirectSurgical Direct, Inc.LRC2026-07-29
00190776422080MillenniumAvalign Technologies, Inc.LRC2026-07-28
00198506092442ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092633ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092664ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092763ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092787ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506092824ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093043ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093050ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093067ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093074ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093098ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093159ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506093227ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-28
00198506091896ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091902ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506091971ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
00198506093623ELMED INCORPORATEDELMED INCORPORATEDLRC2026-07-22
04059453127471Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04059453133809Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-07-16
04250407786571FENTEXFENTEX medical GmbHLRC2024-08-01
04250407785765FENTEXFENTEX medical GmbHLRC2022-12-15
04250407785772FENTEXFENTEX medical GmbHLRC2022-12-15