FDA.reportPublic FDA data

Millennium

Primary DI
00190776365394
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-809803
Device description
Micro Needle Holder
Published
2023-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNMNeedle, ophthalmic suturing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776365394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776365394001907763653941907763653940190776365394

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. 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
+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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G346EEN008Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2026-04-20
08800268430111LYNKS Frontalis SlingLynk Solutec Inc.HNM2026-03-03
G346EEN0132Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2025-12-17
04058935011574Osher Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011581Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011598Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011604Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011611Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011628McPherson Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011635Cohan Needle Holder, Mini CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011642Cohan Needle Holder, Mini CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011659Troutman Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011666Troutman Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011673Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011680Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011697Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011703Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011710Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011727Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011734Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011741Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011758Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011765Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011772Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011789Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011796Derf Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
G346EEN010Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2025-07-07
G223112750WHMC0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNM2025-06-18
G2231138500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNM2025-06-18
G412PH10400MR PHACOCrestpoint Management LimitedHNM2025-06-03