FDA.reportPublic FDA data

Millenium

Primary DI
00190776439828
Brand
Millenium
Company
Avalign Technologies, Inc.
Model
85-71018835
Device description
Castroviejo Kerato Scisso blnt ang., blades, 4.3" 4 1/2" long
Published
2026-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776439828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776439828001907764398281907764398280190776439828

GMDN Terms#

Term, Definition table
TermDefinition
Corneal scissors, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut corneal tissue (e.g., during cataract extraction surgery, corneal transplant surgery). It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes; some designs may additionally be used for cutting sutures and drapes. 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
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
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
00190776437121Millennium1-516450-6752026-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9039901000Surgical DirectSurgical Direct, Inc.HNF2026-10-28
G346ED1010Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2026-10-28
00724995315870V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315887V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315894V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315917V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315924V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315931V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315948V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315955V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315962V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315979V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315986V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995315993V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316006V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316013V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316501V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316518V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316525V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316570V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316587V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316594V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316600V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316655V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316693V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316709V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316716V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316723V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316730V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316747V. MuellerSTERIS Deutschland GmbHHNF2026-10-27