FDA.reportPublic FDA data

Millennium

Primary DI
00190776385194
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-T1432
Device description
Custom Extra Fine Mesh Strainer
Published
2024-08-26
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
KEYStainer, Tissue, Automated

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776385194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776385194001907763851941907763851940190776385194

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
00190776404093Millennium85-670332562026-07-24
00190776404109Millennium85-670332512026-07-24
00190776404116Millennium85-670332762026-07-24
00190776404123Millennium85-670332662026-07-24
00190776404130Millennium85-670332712026-07-24
00190776404147Millennium85-200831492026-07-24
00190776404178Millennium85-520033262026-07-24
00190776404185Millennium85-510002082026-07-24
00190776404192Millennium85-750802482026-07-24
00190776404208Millennium85-200801322026-07-24
00190776404215Millennium85-200801372026-07-24
00190776404222Millennium85-420472272026-07-24
00190776404239Millennium85-140181602026-07-24
00190776405748Millennium85-428302392026-07-24
00190776405755Millennium2-74002026-07-24
00190776405762Millennium85-780694882026-07-24
00190776405779Millennium85-530180862026-07-24
00190776405786Millennium85-770111652026-07-24
00190776405793Millennium85-780703032026-07-24
00190776405809Millennium85-250081402026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00190776184483MillenniumAvalign Technologies, Inc.KEY2021-11-01
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