FDA.reportPublic FDA data

Millennium

Primary DI
00190776355487
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
4-29505
Device description
Luntz-Dodick Trab Punch
Published
2023-11-17
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
HNJPunch, corneo-scleral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNJPunch, Corneo-ScleralOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776355487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776355487001907763554871907763554870190776355487

GMDN Terms#

Term, Definition table
TermDefinition
Corneoscleral punchA hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue (frequently in the form of a disc) from the sclera or cornea of a patient or from grafts taken from cadaver donors. It typically has a set of sharp, hollow tips at the distal end (a rotary mechanism that may be either integral or an attachment) operated by squeezing a two-part handle. The device is used mainly to perform ophthalmic graft implantations or, less frequently, to obtain grafts from the sclera of cadaver donors. 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
00190776437176Millennium1-212EB2026-10-28
00190776437183Millennium1-268EB2026-10-28
00190776437190Millennium1-269EB2026-10-28
00190776437206Millennium1-270-11EB2026-10-28
00190776437213Millennium1-293EB2026-10-28
00190776437220Millennium1-244EB2026-10-28
00190776439811Millenium85-140190932026-10-28
00190776439828Millenium85-710188352026-10-28
00190776439835Millenium85-640033142026-10-28
00190776433796Millennium1-6570502026-10-08
00190776433802Millennium1-6570512026-10-08
00190776433819Millennium1-6570532026-10-08
00190776399221Millennium1-1124282025-05-29
00190776433000Millennium1-161962026-10-26
00190776437060Millennium1-121219-122026-10-26
00190776437077Millennium1-410324C2026-10-26
00190776437084Millennium1-516410-6752026-10-26
00190776437091Millennium1-516420-6752026-10-26
00190776437107Millennium1-516430-6752026-10-26
00190776437114Millennium1-516440-6752026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770419807Bausch + LombBausch & Lomb IncorporatedHNJ2026-04-29
00757770500437Bausch + LombBausch & Lomb IncorporatedHNJ2025-08-15
00194613036690MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086510MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086527MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613086879MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087005MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087012MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087463MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613087555MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613099756MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613100049MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613103453MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108281MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108809MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108816MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613108915MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109646MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109691MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613109707MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110260MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110307MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110390MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110406MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110857MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613110994MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111397MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111908MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613111915MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01
00194613123604MSI Precision Specialty InstrumentsMed Saver, Inc.HNJ2025-08-01