FDA.reportPublic FDA data

Millennium

Primary DI
00190776154516
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
95-2000162063
Device description
"V-Silicone Retainers, comes w/2 screws to fasten to lid, OL 109.22mm (4.30"")"
Published
2020-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776154516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776154516001907761545161907761545160190776154516

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776437329Millennium1-803EB2026-11-02
00190776437336Millennium1-80111EB2026-11-02
00190776437343Millennium1-750EB2026-11-02
00190776437350Millennium1-911172026-11-02
00190776437367Millennium1-BIO11042C2026-11-02
00190776437374Millennium1-SS937182026-11-02
00190776437381Millennium1-620030012026-11-02
00190776437398Millennium1-3104952026-11-02
00190776437404Millennium1-1852312026-11-02
00190776437411Millennium1-1851962026-11-02
00190776437428Millennium72-2358702042026-11-02
00190776437435Millennium72-2358702012026-11-02
00190776437442Millennium1-1103332026-11-02
00190776437459Millennium1-500135L2026-11-02
00190776437466Millennium1-2302142026-11-02
00190776437237Millennium1-121195EB2026-10-30
00190776437244Millennium1-018EB2026-10-30
00190776437251Millennium1-010EB2026-10-30
00190776437268Millennium1-7772EB2026-10-30
00190776437275Millennium1-7082EB2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00385640095433INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095440INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095457INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095464INSTRUSAFESummit Medical, Inc.KCT2026-11-02
00385640095419INSTRUSAFESummit Medical, Inc.KCT2026-10-30
00385640095426INSTRUSAFESummit Medical, Inc.KCT2026-10-30
00385640095372INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095389INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095396INSTRUSAFESummit Medical, Inc.KCT2026-10-29
00385640095402INSTRUSAFESummit Medical, Inc.KCT2026-10-29
07899995223999ORGANIZER BOX VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234322Organizar Box Beyond Full Arch SurgicalSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995234339Organizer Box Intraoral Pro Scanning StarterSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237705Organizer Box Intraoral Pro Scanning PremiumSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237712Beyond Full Arch Surgical KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237729Intraoral Pro Scanning Premium KitSin Sistema de Implante Nacional S/AKCT2026-10-29
07899995237736Intraoral Pro Scanning Starter KitSin Sistema de Implante Nacional S/AKCT2026-10-29
00385640095341INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095358INSTRUSAFESummit Medical, Inc.KCT2026-10-28
00385640095365INSTRUSAFESummit Medical, Inc.KCT2026-10-28
07899995224002SURGICAL KIT VERSALISSin Sistema de Implante Nacional S/AKCT2026-10-28
G476ISTO20X10X2ISTO BIOLOGICS SteriZign Sterilization TraySterizign Precision Technologies, LLCKCT2026-10-27
00385640095327INSTRUSAFESummit Medical, Inc.KCT2026-10-26
00385640095334INSTRUSAFESummit Medical, Inc.KCT2026-10-26
03701045278962KONTACTBIOTECH DENTALKCT2026-10-26
03701045278979KONTACTBIOTECH DENTALKCT2026-10-26
06973993446022Sterilization CassetteAlliedstar Medical Equipment Co., Ltd.KCT2026-10-26
00385640095303INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00385640095310INSTRUSAFESummit Medical, Inc.KCT2026-10-23
00642356006673Mastel SurgicalMastel Surgical Inc.KCT2026-10-23