FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776329549
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
85-33085512
Device description
Stamay Needle,
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHRNEEDLE, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHRNeedle, Gastro-UrologyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776329549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776329549001907763295491907763295490190776329549

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, reusableA sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. 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
00190776397050Millennium85-160P208832026-07-16
00190776397067Millennium85-530366172026-07-16
00190776397074Millennium85-720391422026-07-16
00190776397081Millennium14-50052026-07-16
00190776397104Millennium85-770498932026-07-16
00190776397111Millennium85-230675902026-07-16
00190776397128Millennium85-640041212026-07-16
00190776397135Millennium85-710186192026-07-16
00190776397142Millennium85-300243682026-07-16
00190776397159Millennium85-780096162026-07-16
00190776397166Millennium85-900102152026-07-16
00190776397173Millennium85-520023162026-07-16
00190776397180Millennium85-528137762026-07-16
00190776397197Millennium85-520111272026-07-16
00190776397463Millennium85-140308682026-07-16
00190776398484Millennium85-800001202026-07-16
00190776398651Millennium85-590P015832026-07-16
00190776398668Millennium85-710378692026-07-16
00190776398682Millennium85-710369342026-07-16
00190776398699Millennium85-710374012026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770413867Bausch + LombBausch & Lomb IncorporatedFHR2025-08-18
00757770425150Bausch + LombBausch & Lomb IncorporatedFHR2025-08-18
10810235030638"Rigid Needle 21 GA x 0.5"" (0,8 x 13 mm)"MERZ NORTH AMERICA, INC.FHR2024-10-21
00190776248659AvalignAvalign Technologies, Inc.FHR2023-06-23
14026704791665PILLINGTELEFLEX INCORPORATEDFHR2022-12-08
54026704791663PILLINGTELEFLEX INCORPORATEDFHR2022-12-08
00827002145191CookCOOK INCORPORATEDFHR2020-10-02
00827002537408CookCOOK INCORPORATEDFHR2020-10-02
10885403205293V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403205309V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403205316V. MuellerSTERIS CORPORATIONFHR2018-09-17
10885403050725V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050732V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050336V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050343V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050350V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050121V. MuellerCAREFUSION 2200, INCFHR2018-08-30
10885403050138V. MuellerCAREFUSION 2200, INCFHR2018-08-30