FDA.reportPublic FDA data

Millennium

Primary DI
00190776398675
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-71036934
Device description
Graefe Iris Forcep
Published
2026-07-21
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
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776398675PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776398675001907763986751907763986750190776398675

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. 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
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
07612717072169FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
07612717072176FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
07612717072190FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
B382SD902769010Surgical DirectSurgical Direct, Inc.HNR2026-10-28
00724995266707Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266714Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266721Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266738Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266745Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266769Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266776Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266783Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995316280V. MuellerSTERIS Deutschland GmbHHNR2026-10-27
00190776437039MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776437046MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776437053MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776435721MillenniumAvalign Technologies, Inc.HNR2026-10-21
00190776435318MillenniumAvalign Technologies, Inc.HNR2026-10-19
G346EA32C0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-16
00190776434885MillenniumAvalign Technologies, Inc.HNR2026-10-14
00190776434984MillenniumAvalign Technologies, Inc.HNR2026-10-14
00192896123939Bishop Harmon Tissue ForcepsSONTEC INSTRUMENTS, INC.HNR2026-10-14
G346EA41VSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-14
00757770602506Bausch + LombBausch & Lomb IncorporatedHNR2026-10-09
00190776436209MillenniumAvalign Technologies, Inc.HNR2026-10-08
00190776433734MillenniumAvalign Technologies, Inc.HNR2026-10-07
00190776436155MillenniumAvalign Technologies, Inc.HNR2026-10-07
0081748902541323ga DEX™ Morris ILM ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsKATALYST SURGICAL LLCHNR2026-10-07