FDA.reportPublic FDA data

Millennium

Primary DI
00190776360238
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
85-72053810
Device description
Fox Eye Shield,
Published
2023-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOYShield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)Ophthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776360238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776360238001907763602381907763602380190776360238

GMDN Terms#

Term, Definition table
TermDefinition
Eye irrigation shield, reusableA device intended to be used with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye (e.g., to flush the cornea and sclera of irritating particulates/chemicals). It is a curved/cup-like device, intended to be placed over the eye surface, with a port to allow entry of the irrigation solution; it may include a length of tubing. It is intended to be connected to an irrigation solution reservoir/pump. 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
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840479203355SAFETY GLASSESRELIANCE ORTHODONTIC PRODUCTS INCHOY2026-03-12
00840479203362SAFETY GLASSESRELIANCE ORTHODONTIC PRODUCTS INCHOY2026-03-12
06973541158100REC SAFETY GOGGLESTaizhou YuanMing Glasses Co., LtdHOY2026-02-11
06973541158117 REC SAFETY GOGGLESTaizhou YuanMing Glasses Co., LtdHOY2026-02-11
00620974004288BetterShieldSouthmedic IncorporatedHOY2025-12-19
00757770455409Bausch + LombBausch & Lomb IncorporatedHOY2025-08-22
00883205038227Ease-In-ShieldsULTRADENT PRODUCTS, INC.HOY2025-08-19
00883205038234Ease-In-ShieldsULTRADENT PRODUCTS, INC.HOY2025-08-19
00194613026080MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026165MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026172MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026189MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613026219MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613056322MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613056346MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613103637MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613103644MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104269MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104276MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104337MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613104979MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118723MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118730MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118907MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118914MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118921MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118938MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613118945MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613122546MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01
00194613122553MSI Precision Specialty InstrumentsMed Saver, Inc.HOY2025-08-01