FDA.reportPublic FDA data

Millennium

Primary DI
00190776360221
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
3-3095
Device description
Universal Trephine Handle
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
HRHTrephine, manual, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776360221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776360221001907763602211907763602210190776360221

GMDN Terms#

Term, Definition table
TermDefinition
Corneal trephine handleA hand-held, ophthalmic surgical device used to hold an exchangeable trephine (cylindrical cutting blade) so that it can be manually rotated with downward pressure by a surgeon in order to cut and remove circular pieces of corneal tissue (corneal buttons) or scleral tissue. It is typically made of high-grade stainless steel and may have a knurled portion on the shaft to provide a grip. 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
00810158218468PRINCETONPrinceton Medical Group, Inc.HRH2026-01-15
00852194002106HAI TrephineHightech American Industrial Labs IncHRH2025-12-16
00757770422494Bausch + LombBausch & Lomb IncorporatedHRH2025-08-08
00194613037956MSI Precision Specialty InstrumentsMed Saver, Inc.HRH2025-08-01
00194613111380MSI Precision Specialty InstrumentsMed Saver, Inc.HRH2025-08-01
00757770435432Bausch + LombBausch & Lomb IncorporatedHRH2025-07-30
G412PH98270MR PHACOCrestpoint Management LimitedHRH2025-06-09
G412PH62270MR PHACOCrestpoint Management LimitedHRH2025-05-27
05056100712935Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712942Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712799Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713079Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712959Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712966Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712973Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712980Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712997Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713000Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713017Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713024Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100712898Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713048Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713055Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
05056100713062Lions World Vision InstituteNETWORK MEDICAL PRODUCTS LIMITEDHRH2025-03-11
00757770430345Bausch + LombBausch & Lomb IncorporatedHRH2024-11-21
00757770435036Bausch + LombBausch & Lomb IncorporatedHRH2024-11-21
00757770455867Bausch + LombBausch & Lomb IncorporatedHRH2024-11-21
00192896120235Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15
00192896120242Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15
00192896120259Corneal Trephine BladeSONTEC INSTRUMENTS, INC.HRH2024-10-15