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
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
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