FDA.reportPublic FDA data

Millennium

Primary DI
00190776401627
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-41682520
Device description
Steinhauser Mucosal Retractor Spanner, Complete System
Published
2025-06-11
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
00190776401627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776401627001907764016271907764016270190776401627

GMDN Terms#

Term, Definition table
TermDefinition
ENT surgical procedure kit, non-medicated, reusableA collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. 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
00190776391683CONDUIT ZERO-P VA4514021002026-07-10
00190776391690CONDUIT ZERO-P VA4514021102026-07-10
00190776391706CONDUIT ZERO-P VA4514021202026-07-10
00190776391713CONDUIT ZERO-P VA4514030502026-07-10
00190776391720CONDUIT ZERO-P VA4514030602026-07-11
00190776391737CONDUIT ZERO-P VA4514030702026-07-11
00190776391744CONDUIT ZERO-P VA4514030802026-07-11
00190776391751CONDUIT ZERO-P VA4514030902026-07-11
00190776391768CONDUIT ZERO-P VA4514031002026-07-11
00190776391775CONDUIT ZERO-P VA4514031102026-07-11
00190776391782CONDUIT ZERO-P VA4514031202026-07-11
00190776391799CONDUIT ZERO-P VA4515010502026-07-11
00190776391805CONDUIT ZERO-P VA4515010602026-07-11
00190776391812CONDUIT ZERO-P VA4515010702026-07-11
00190776391829CONDUIT ZERO-P VA4515010802026-07-11
00190776391836CONDUIT ZERO-P VA4515010902026-07-11
00190776391843CONDUIT ZERO-P VA4515011002026-07-11
00190776391850CONDUIT ZERO-P VA4515011102026-07-11
00190776391867CONDUIT ZERO-P VA4515011202026-07-11
00190776391874CONDUIT ZERO-P VA4515020502026-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250407741976FENTEXFENTEX medical GmbHLRC2023-06-14
04250407729448FENTEXFENTEX medical GmbHLRC2022-12-12
04250407730406FENTEXFENTEX medical GmbHLRC2022-12-12
04250407731328FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732288FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732295FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732332FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732912FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732929FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732936FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732943FENTEXFENTEX medical GmbHLRC2022-12-12
04250407732950FENTEXFENTEX medical GmbHLRC2022-12-12
04250407733063FENTEXFENTEX medical GmbHLRC2022-12-12
04250407733865FENTEXFENTEX medical GmbHLRC2022-12-12
04250407733872FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734282FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734466FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734473FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734480FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734497FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734794FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734947FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734954FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734961FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734978FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734985FENTEXFENTEX medical GmbHLRC2022-12-12
04250407734992FENTEXFENTEX medical GmbHLRC2022-12-12
04250407735005FENTEXFENTEX medical GmbHLRC2022-12-12
04250407735203FENTEXFENTEX medical GmbHLRC2022-12-12
04250407735210FENTEXFENTEX medical GmbHLRC2022-12-12