FDA.report

MILLENNIUM

Primary DI
00190776374013
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
85-72052987
Device description
Piston for 9-11mm trephine blades
Published
2023-09-28
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

Related Records

Contact Domains

Product Codes

CodeName
HRHTrephine, manual, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776374013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776374013001907763740131907763740130190776374013

GMDN Terms

TermDefinition
Corneal trephine manual instrumentA hand-held, ophthalmic surgical instrument, constructed as a one-piece handle with trephine (not an exchangeable component) that is manually rotated with downward pressure by a surgeon in order to cut and remove circular pieces of corneal tissue (corneal buttons). The trephine portion consists of a shaft that has at its working end an extremely sharp, bevelled, cylindrical cutting edge. Healthy tissue may be taken from cadavers for transplant to the recipient, where the defect cornea is cut and removed for acceptance of the replacement. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 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