FDA.reportPublic FDA data

Millennium

Primary DI
00190776419103
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-71018177
Device description
Iris Scissor
Published
2026-08-23
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
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776419103PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776419103001907764191031907764191030190776419103

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, conventional-hinge, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or spring handles, and is available with various blade designs and sizes. 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
18772891096product.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
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
00190776439828MilleniumAvalign Technologies, Inc.HNF2026-10-28
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