FDA.report

MILLENNIUM

Primary DI
00190776355401
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
3-0390
Device description
Tooke Corneal Knife,
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
HNNKnife, ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776355401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776355401001907763554011907763554010190776355401

GMDN Terms

TermDefinition
Ophthalmic knife, reusableA hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. 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
00810163790546Diamatrix Ltd.DiamatrixHNN2026-03-24
00813059013491Dacrios Opthalmic KnivesDiamatrixHNN2026-03-19
00860013297930Ziplyft Upper Eyelid Lift KitOsheru, L.L.C.HNN2026-02-23
00757770635382Bausch + LombBausch & Lomb IncorporatedHNN2026-01-27
00850072675008MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675015MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675022MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675039MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675046MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675053MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675060MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675077MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675084MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675091MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675107MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675114MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675121MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675138MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675145MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675152MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675169MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675176MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675183MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675190MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675206MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675213MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675220MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675237MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675244MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16
00850072675251MakEdgeMAKVIN SURGICAL LLCHNN2025-12-16