FDA.reportPublic FDA data

Millennium

Primary DI
00190776395476
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-76082628
Device description
Humby Dermatome Knife
Published
2026-07-14
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
EMFKnife, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776395476PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776395476001907763954761907763954760190776395476

GMDN Terms#

Term, Definition table
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 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
00190776395353Millennium85-220117852026-07-14
00190776395360Millennium85-120P088052026-07-14
00190776395445Millennium85-610149882026-07-14
00190776395469Millennium85-200067112026-07-14
00190776395483Millennium85-620343252026-07-14
00190776395490Millennium85-160514552026-07-14
00190776395506Millennium85-780041542026-07-14
00190776395513Millennium85-780041492026-07-14
00190776395520Millennium85-640030002026-07-14
00190776395537Millennium85-200936872026-07-14
00190776395544Millennium85-780027742026-07-14
00190776395551Millennium85-780942452026-07-14
00190776395568Millennium85-200771592026-07-14
00190776395575Millennium85-431123682026-07-14
00190776395582Millennium85-431120402026-07-14
00190776395599Millennium85-780694382026-07-14
00190776395605Millennium85-520029402026-07-14
00190776395629Millennium85-200771522026-07-14
00190776395636Millennium85-320P072422026-07-14
00190776395643Millennium85-510127092026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810189450691Surgical DesignSurgical Design, Inc.EMF2026-06-06
00810189450707Surgical DesignSurgical Design, Inc.EMF2026-06-06
00198506085659ELMED INCORPORATEDELMED INCORPORATEDEMF2025-10-02
10888277370647MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-02-14
10888277377615MEDLINEMEDLINE INDUSTRIES, INC.EMF2025-01-21
00860010523902VECTRRafael Medical Devices, LLCEMF2025-01-10
00842180160613ELMEDELMED INCORPORATEDEMF2023-01-30
00842180147737ELMEDELMED INCORPORATEDEMF2022-12-22
14026704810861PILLINGTELEFLEX INCORPORATEDEMF2022-12-08
00192896113701Cottle Mucosa KnifeSONTEC INSTRUMENTS, INC.EMF2022-09-15
00847399017239MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
00847399017246MicroAire® Microaire Surgical Instruments LLCEMF2022-06-15
10888277370623MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
10888277370630MedlineMEDLINE INDUSTRIES, INC.EMF2022-05-12
00847399016003MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016010MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016034MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016935MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
00847399016942MicroAire® Microaire Surgical Instruments LLCEMF2021-10-25
20630140057523CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
20630140057530CARDINAL HEALTHCardinal Health 200, LLCEMF2021-06-11
00848782025527StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025541StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025572StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025602StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025633StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025657StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025671StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025688StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29
00848782025763StylusSurgical Specialties México, S. de R.L. de C.V.EMF2021-03-29