FDA.reportPublic FDA data

Millennium

Primary DI
00190776204808
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
92-01412S
Device description
KELMAN CYSTOTOME KNIFE SHARP GA
Published
2021-11-02
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
HNYCystotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNYCystotomeOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776204808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776204808001907762048081907762048080190776204808

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusableA rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a reusable device intended to be sterilized prior to use.

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
00841668145968BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668145982BLINKKATENA PRODUCTS, INC.HNY2026-03-23
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00841668146002BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146019BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146071BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146095BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146132BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146149BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146170BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146194BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146200BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146231BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00841668146248BLINKKATENA PRODUCTS, INC.HNY2026-03-23
00757770416783Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00757770429943Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00757770433896Bausch + LombBausch & Lomb IncorporatedHNY2025-08-22
00194613002251MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01
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00194613104672MSI Precision Specialty InstrumentsMed Saver, Inc.HNY2025-08-01