FDA.reportPublic FDA data

Millennium

Primary DI
00190776184483
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-T1436
Device description
CUST FINE DOUBLE MESH STRAINER DIAMETER
Published
2021-11-01
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
KEYSTAINER, TISSUE, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEYStainer, Tissue, AutomatedPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776184483PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776184483001907761844831907761844830190776184483

GMDN Terms#

Term, Definition table
TermDefinition
Urine strainerA device designed to collect stones (calculi) from urine during normal micturition (urination). It is typically designed as a sieve-like container with handles for holding and emptying, and is typically mounted into a funnel/holder system that may be attached to a dedicated treatment table or chair. The collected stones are typically sent to the clinical laboratory for examination and composition determination to facilitate patient diagnosis and/or therapy. 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
00190776432256Millennium1-9317432026-09-24
00190776432263Millennium1-7023075732026-09-24
00190776432270Millennium1-7023075742026-09-24
00190776432287Millennium1-2245100402026-09-24
00190776432294Millennium1-2810170002026-09-24
00190776432300Millennium100-S03285FGD202026-09-24
00190776432317Millennium100-S03286FGD452026-09-24
00190776432324Millennium72-586006C2026-09-24
00190776432331Millennium1-831100202026-09-24
00190776432348Millennium72-52515962026-09-24
00190776432355Millennium1-9314972026-09-24
00190776432362Millennium1-4751872026-09-24
00190776432379Millennium1-CH26102026-09-24
00190776432386Millennium72-52103236C32026-09-24
00190776432393Millennium72-241180KB2026-09-24
00190776432409Millennium1-CP4520022026-09-24
00190776432416Millennium72-52505182026-09-24
00190776432423Millennium1-GS4259402026-09-24
00190776432430Millennium100-S02681TR2026-09-24
00190776432447Millennium100-S02683TR2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776385194MillenniumAvalign Technologies, Inc.KEY2024-08-26
00810119676283Xmatrx® EliteBIOGENEX LABORATORIESKEY2023-04-20
00810119676290Xmatrx® InfinityBIOGENEX LABORATORIESKEY2023-04-20
00810119676306Xmatrx® MINIBIOGENEX LABORATORIESKEY2023-04-20
00810119676313NanoVIP®BIOGENEX LABORATORIESKEY2023-04-20
00810119676320i6000™ InfinityBIOGENEX LABORATORIESKEY2023-04-20
00810119676337i6000™ DiagnosticsBIOGENEX LABORATORIESKEY2023-04-20
00810119676368Xmatrx® NanoBIOGENEX LABORATORIESKEY2023-04-20
00884999048843VP2000ABBOTT MOLECULAR INC.KEY2023-02-13
00884999048478VP2000ABBOTT MOLECULAR INC.KEY2019-10-31
00884999047310VP2000ABBOTT MOLECULAR INC.KEY2018-06-01
00884999046108VP2000ABBOTT MOLECULAR INC.KEY2016-11-21
00884999046115VP2000ABBOTT MOLECULAR INC.KEY2016-11-21
00884999046122VP2000ABBOTT MOLECULAR INC.KEY2016-11-21
00884999046146VP2000ABBOTT MOLECULAR INC.KEY2016-11-21
00884999046153VP2000ABBOTT MOLECULAR INC.KEY2016-11-21
00884999001916VP2000ABBOTT MOLECULAR INC.KEY2015-02-20
00884999037595VP2000ABBOTT MOLECULAR INC.KEY2015-02-20