FDA.reportPublic FDA data

Millennium

Primary DI
00190776304157
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-MDS1324923
Device description
Castroviejo Caliper 40mm, 17cm length, curved, 45 degree angle
Published
2023-11-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HOECaliper, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOECaliper, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776304157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776304157001907763041571907763041570190776304157

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic calliperA hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye. Some types, known as a blepharometer, can be used to measure the thickness of the eyelid and the force of the lid closure.

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
00190776417116Millennium85-170103022026-08-19
00190776417123Millennium85-170103072026-08-19
00190776417130Millennium85-150210582026-08-19
00190776417147Millennium85-200817712026-08-19
00190776417154Millennium85-770057162026-08-19
00190776417161Millennium85-538056882026-08-19
00190776417178Millennium85-320071642026-08-19
00190776417192Millennium85-780866482026-08-19
00190776417208Millennium85-330848342026-08-19
00190776417215Millennium85-330848142026-08-19
00190776417222Millennium85-330848192026-08-19
00190776417239Millennium85-638014582026-08-19
00190776417246Millennium85-230826882026-08-19
00190776417253Millennium85-230811872026-08-19
00190776417710Millennium85-230811922026-08-19
00190776417727Millennium85-124162352026-08-19
00190776426569Millennium1-466322026-08-19
00190776426576Millennium92-F1750T2026-08-19
00190776426583Millennium1-911-52026-08-19
00190776426590Millennium1-910-52026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506092619ELMED INCORPORATEDELMED INCORPORATEDHOE2026-07-28
00198506092022ELMED INCORPORATEDELMED INCORPORATEDHOE2026-07-27
00850083275891Intrace USAPILOTIS TECH LLCHOE2026-07-03
04251047924378Castroviejo CaliperA1 Medical GmbHHOE2026-05-29
00198506089053ELMED INCORPORATEDELMED INCORPORATEDHOE2026-03-03
00852194002090HAI CaliperHightech American Industrial Labs IncHOE2025-12-16
09348811124524INKAThe Trustee for KAISER FAMILY TRUSTHOE2025-11-28
00810207782575Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00810207782582Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHOE2025-11-24
00194613007409MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007423MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007430MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007454MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613007508MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613051952MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
00194613112783MSI Precision Specialty InstrumentsMed Saver, Inc.HOE2025-08-01
04058935011055Castroviejo CaliperBausch & Lomb GmbHHOE2025-07-10
04058935011062Castroviejo Marking CaliperBausch & Lomb GmbHHOE2025-07-10
G412PH94030MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH94071T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
G412PH9408T0MR PHACOCrestpoint Management LimitedHOE2025-06-09
G2231113910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHOE2025-06-04
G412PH20330MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH61270MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62500MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62510MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62520MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62540MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62550MR PHACOCrestpoint Management LimitedHOE2025-05-27
G412PH62560MR PHACOCrestpoint Management LimitedHOE2025-05-27