FDA.reportPublic FDA data

Millennium

Primary DI
00190776414375
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
92-H0208
Device description
Kimura Platinum Spatula Round Knurled Handle
Published
2025-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNDSpatula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776414375PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776414375001907764143751907764143750190776414375

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776436902Millennium1-5053602026-10-23
00190776436919Millennium1-3994896SS2026-10-23
00190776436926Millennium1-3110196SS2026-10-23
00190776436933Millennium1-3139696SS2026-10-23
00190776436940Millennium1-399481SS2026-10-23
00190776436957Millennium1-45382026-10-23
00190776436964Millennium72-321001IM2026-10-23
00190776436971Millennium72-321002IM2026-10-23
00190776436988Millennium72-321003IM2026-10-23
00190776436995Millennium1-3417302026-10-23
00190776437008Millennium72-1371112026-10-23
00190776437015Millennium1-MPR1049012026-10-23
00190776437022Millennium1-MPR1049022026-10-23
00190776437039Millennium92-F2710CT2026-10-23
00190776437046Millennium92-F2050T2026-10-23
00190776437053Millennium92-F2710T2026-10-23
00190776436827Millennium72-3130082OLY2026-10-22
00190776436834Millennium1-1211272026-10-22
00190776436841Millennium63-AOCOMES2026-10-22
00190776436858Millennium100-S03420NSR2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G346EP1880Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-10-22
00724995317683V. MuellerSTERIS Deutschland GmbHHND2026-10-21
00724995317690V. MuellerSTERIS Deutschland GmbHHND2026-10-21
05056785304739Koch SpatulaBLINK MEDICAL LIMITEDHND2026-10-21
00190776434625MillenniumAvalign Technologies, Inc.HND2026-10-12
G346EC1734SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-10-01
03700483630240MORIAMORIA SAHND2026-09-25
00190776431464MillenniumAvalign Technologies, Inc.HND2026-09-22
00190776427801MillenniumAvalign Technologies, Inc.HND2026-08-26
00190776427924MillenniumAvalign Technologies, Inc.HND2026-08-26
B382S344933000Surgical DirectSurgical Direct, Inc.HND2026-07-31
B382S340861270Surgical DirectSurgical Direct, Inc.HND2026-07-29
G346EP400Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-07-23
00190776403836MillenniumAvalign Technologies, Inc.HND2026-07-21
00190776400385MillenniumAvalign Technologies, Inc.HND2026-07-17
G346EP175RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-07-06
00850083275983Intrace USAPILOTIS TECH LLCHND2026-07-03
G4533306290PEAK MEDICALPeak Medical Distribution Inc.HND2026-06-24
04251047903571Rowen Phaco Spatula & Bechert Nucleus RotatorA1 Medical GmbHHND2026-06-09
00757770688548Bausch + LombBausch & Lomb IncorporatedHND2026-05-11
00190776420994MillenniumAvalign Technologies, Inc.HND2026-04-30
00757770501229Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770505753Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511006Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511020Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511037Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511075Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770520138Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770522682Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
G346EP02SSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-23