FDA.report

Millennium

Primary DI
00190776405151
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-3712655
Device description
Walter (mod Cottle) Septum Specula w/ Extremely Thin Blades and Set Screw Size 2 55mm
Published
2025-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRCInstrument, Ent Manual Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776405151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776405151001907764051511907764051510190776405151

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1(877)289-1096product.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 DIBrandModelCatalogPublished
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417970MillenniumAvalign Technologies, Inc.LRC2026-03-23
00198506089756ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-23
00198506089657ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-17
00198506089534ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089541ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089558ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089572ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
08904461031073OSSEOUS-Ear/Nasal ExtractorEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
08904428798377OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
00198506088926ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-03
00190776417420MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417475MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417482MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417543MillenniumAvalign Technologies, Inc.LRC2026-02-27
00198506088865ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-25
00198506088469ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-23
00198506088544ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-23
00190776416546MillenniumAvalign Technologies, Inc.LRC2026-02-16
00190776415914MillenniumAvalign Technologies, Inc.LRC2026-02-06
00190776415778MillenniumAvalign Technologies, Inc.LRC2026-02-04
04059453133779Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-02-02
00198506088346ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-30
04059453133755Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-01-29
09348811102638INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-01-28
00190776415495MillenniumAvalign Technologies, Inc.LRC2026-01-27
00198506088070ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-23
00198506087813ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-16
00198506087899ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-15
00198506087912ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-15
00198506087929ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-15