FDA.reportPublic FDA data

Millennium

Primary DI
00190776360276
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
3-5652
Device description
"Carter Sphere Introducer OL 124mm (4 7/8"")"
Published
2023-02-22
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
HNPIntroducer, sphere

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNPIntroducer, SphereOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776360276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776360276001907763602761907763602760190776360276

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. 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
00190776429034Millennium1-30862026-09-04
00190776429058Millennium1-309332026-09-04
00190776429065Millennium1-BV088R2026-09-04
00190776429072Millennium1-3K7.52026-09-04
00190776429089Millennium1-6739523MC2026-09-04
00190776429096Millennium1-6739543M2026-09-04
00190776429102Millennium63-G92230102026-09-04
00190776429119Millennium1-CH56952026-09-04
00190776429126Millennium1-FK5322026-09-04
00190776429133Millennium72-2425505OLY12026-09-04
00190776429140Millennium100-S02685TRS2026-09-04
00190776423926Millennium85-220034192026-08-27
00190776423933Millennium85-530183732026-08-27
00190776423940Millennium85-710080342026-08-27
00190776423957Millennium85-170106772026-08-27
00190776423964Millennium85-610161112026-08-27
00190776423971Millennium85-420413942026-08-27
00190776423988Millennium85-314212382026-08-27
00190776423995Millennium85-580028682026-08-27
00190776424008Millennium85-650048782026-08-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613011734MSI Precision Specialty InstrumentsMed Saver, Inc.HNP2025-03-21
00757770408320Bausch + LombBausch & Lomb IncorporatedHNP2024-11-20
00887482040010Symmetry FoxASPEN SURGICAL PRODUCTS, INC.HNP2024-08-20
14026704802262PILLINGTELEFLEX INCORPORATEDHNP2022-12-08
54026704802260PILLINGTELEFLEX INCORPORATEDHNP2022-12-08
00842331166532Novo Surgical Inc. NOVO SURGICAL, INC.HNP2022-11-13
00190776072155AvalignAvalign Technologies, Inc.HNP2021-11-03
13760087126386SPHERE INTRODUCERFCI S A S FCI 20 22HNP2021-05-30
00190660109325Ambler SurgicalAMBLER SURGICAL CORP.HNP2021-01-07
00841668110836Sphere IntroducerKATENA PRODUCTS, INC.HNP2020-09-14
04046964686665AESCULAPAESCULAP, INC.HNP2020-08-25
03760087126389Orbital sphere implant introducerFCI S A S FCI 20 22HNP2020-02-26
00192896019317CARTER SPHERE INTRODUCERSONTEC INSTRUMENTS, INC.HNP2018-09-14
05060171621850Orbital Implant InserterCERAMISYS LTDHNP2015-07-31